paradigma - Axelmed · total of 93 Axelmed ® Paradigma by different operators with different...

paradigma

life from titanium

“Everythingshould be made

as simple as possible, but not simpler.”

(Albert Einstein)

Sometimes I wonder what is our main objective?

What fuels our perseverance and the constant pursuit of “I can do better”…

and what will the real reward to all our

efforts and commitment to this loved profession be?

…every day we recreate nature using knowledge,

technology, materials, our hands…

maybe the best reward life can give us is a simple smile.

Our Mission

1

3

4

5

6

2

paradigma

04

Crestal or Subcrestal

placement

Axelmed® Paradigma®

EU Registered Design

No 002938092-0001

®

life from titanium

References Bibliography(1) Cochrane Database Syst Rev. 2014 Jul 22;7

(2) Int J Oral Maxillofac Implants, 2003; 18(5):659–66.

(3) J Long Term Eff Med Implants. 2014;24(2-3):109-19.

(4) Int J Oral Maxillofac Implants, 2013 May-Jun; 28(3) 815-23

(5) J Prosthet Dent. 2016 Sep - Systematic Review

(6) Clin Oral Implants, Res 2010 feb; 21(2) 129-36

Machined Surface

1The surface with the lowest risk of

developing peri-implantitis.(1)

Microstructured High Purity Surface (SAP)

2Sandblasted small grit

Acid etched triple attack

Plasma Double treatment

to reduce healing time.(2)

Flat Apex

3Prevent accidental injury to noble

structures and create a better

stress and strain distribution.(3)

Back Tapered and Platform switching

4Greater amount of bone at the crest level and

greater support for the soft tissue.(4)

Microthread

5Reduce stress and promote new bone

formation.(5)

Optimized Thread Design

6Trapezoidal design with decreasing

depth to optimize the primary stability.(6)

05

06

®

implant-prosthetic 1

different implant 5

on

e

07

life from titanium

connection

design

The presence of a machined surface in combination with microthreads, allows to reduce the risk of developing peri-implantitis without compro-mising the stability of marginal bone levels.

The minimally-rough surface and micro geometry of the implant body are achieved by sand blasting with small grit of pure Al

2O

3, followed by

a triple acid treatment. This roughness allows to accelerate the osteo-integration process.

The treatment with Plasma Argon, done before the process of gamma sterilization, allows for elimination of any organic residues on the implant surface and the adherent endotoxins. The only Gamma Ray sterilization treatment is able to kill the cellular components but it’s not capable of removing their structure and this could trigger inflammatory reactions by the host tissue.

All surface treatments are developed and made in our factory, following severe protocols and certified quality control.

3D Designing Acidification SAP Analysys Packaging

Precise Milling Dimensional Check Sandblasting Surface Checking

08

SAP surface: Sand-Blasting,

life from titanium

Implant Surface Identification Standard (ISIS) is a codification system developed by Dohan et al.* for the chemical and mor-phological characterization of dental implant surfaces. Follow-ing the Dohan protocol and us-ing the same type of analysis (performed by an external inde-pendent laboratory) we com-pared the surface of Axelmed®

Paradigma® with those of the main implant brands worldwide. In particular it’s important to take into account:

• the percentage of pollution and

contamination present on the sur-

face (Bar Chart A).

• the percentage of free exposed ti-

tanium on the surface (Bar Chart B).

*David M. Dohan Ehrenfest et al.

ISIS identification cards of 62 implant surfaces. Part 1 - POSEIDO. 2014;2(1) 7

17

%

Average

Alpha Bio SPI

Magitech MS2010

Tecom Implantology REP

Dentsply Ankylos

Straumann Standard Plus (SLActive)

Implant Direct SwissPlant

Anthogyr BCP

Neodent Titamax Ti Ex (Neoporos)

MegaGen AnyRidge (Xpeed)

MegaGen AnyRidge (Xpeed Plus)

Nobel Biocare Replace

Straumann Roxolid (SLActive)

Cowellmedi Inno

BTI Interna

Biohorizons RBT

Blue Sky Bio ActivFluor

DIO BioTite-M

Shinhung Luna (RBM+)

Keystone Genesis

Thommen Element

Ospol

BioSAF IN Winsix WMRS

Bredent blueSky

MIS Seven

Osstem RBM USII

Tekka In-Kone (SA2)

Camlog Screwline

Osstem SA TSIII

Dentsply Xive S Plus

SERF EVL Plus

Dentsply Frialit Plus

Straumann Standard Plus (SLA)

Sweden&Martina Kohno (HRPS)

Dentium SuperLine

AstraTech Osseospeed TX

Sweden&Martina Kohno (DES HRPS)

GC Genesio Plus Re V

Biomet 3I OsseoTite 2

0 7,5 15 22,5

TITANIUM %

Bar Chart B

Axelmed Paradigma

AstraTech Osseospeed TX

Cowellmedi Inno

GC Genesio Plus Re V

MIS Seven

BTI Interna

Biohorizons RBT

Biomet 3I OsseoTite 2

Neodent Titamax Ti Ex (Neoporos)

Anthogyr BCP

BioSAF IN Winsix WMRS

Straumann Standard Plus (SLA)

Dentsply Xive S Plus

Straumann Standard Plus (SLActive)

Camlog Screwline

Nobel Biocare Replace

Ospol

SERF EVL Plus

Tekka In-Kone (SA2)

Bredent blueSky

Osstem RBM USII

Sweden&Martina Kohno (DES HRPS)

Blue Sky Bio ActivFluor

Dentium SuperLine

Implant Direct SwissPlant

Axelmed ParadigmaSweden&Martina Kohno (HRPS)

MegaGen AnyRidge (Xpeed Plus)

Tecom Implantology REP

MegaGen AnyRidge (Xpeed)

Straumann Roxolid (SLActive)

Keystone Genesis

Alpha Bio SPI

Osstem SA TSIII

Dentsply Frialit Plus

Dentsply Ankylos

Magitech MS2010

DIO BioTite-M

Thommen Element

Shinhung Luna (RBM+)

0 2,5

1,7

% 5 7,5 10

Average

Bar Chart A

POLLUTION %

17

09

Acid-Etching, Plasma Treatment

OBJECTIVES

MATERIAL AND METHODS

OBJ

MATAA

JECTIVES

TTERIAL AND METHODS

General Data

In the period between November 2014 and

April 2016, 29 patients received consecutively a

total of 93 Axelmed® Paradigma® by different

operators with different levels of surgical

skills. Of the 93 implants, 39 (41.9%) were

loaded immediately, while the remaining 54

(58,1%) were loaded 10 weeks after the place-

ment. 63 (67.7%) Axelmed® Paradigma®

implants were used in a one-step technique,

while the remaining 30 (32.3%) received a

two-phase approach.

Torque insertion was evaluated, postoperative

Rx were taken at T0 (immediately after

surgery), T1 (1 month), T2 (3 months), T3 (1

year) and the follow up was between 4 and 16

months.

Healed Sites

75,3%

44,1%

Mandibular

Patients

Implants

Implants Failure

Maxillary

Mandibular

One-Step Technique

Post-Extraction Sites

Healed Sites

Immediate Loading

Delayed Loading

29

93

2

52

41

30

23

70

39

54

2,1%

55,9%

44,1%

Two-Steps Technique

63 67,7%

32,3%

24,7%

75,3%

41,9%

58,1%

Obtaining a good primary stability is one of the

main objectives during a dental implant place-

ment procedure and the specific geometries

for each Axelmed® Paradigma® diameter were

developed to satisfy this requirement. The

present report aims at analysing this feature

in different clinical conditions.

10

A prospective study on the evaluation of

RESULTS

DISCUSSION

RESULTSLL

DISCUSSION

Torque Value Distribution

2 implants (2.1%) failed, both in the maxilla,

both placed immediately after tooth extraction

and both treated with an immediate loading

protocol where the initial insertion torque was

50 Ncm in presence of a III Class bone quality

(Lekholm and Zarb, 1985). 23 implants (24.7%)

were placed in post-extraction sockets, while

70 (75.3%) were in healed sites. The 93

Axelmed® Paradigma® received an initial

torque with its distribution summarized in the

bar graph. These values were recorded using

the surgical motor Intrasurgery 2.0.

Literature data indicate that it’s desirable to

reach a minimum value of 35 Ncm to proceed

with an immediate loading protocol. However,

some authors advise against using very high

torque values (above 70 Ncm) to avoid possible

necrosis around the implant fixture. The data

and the experience in this report indicate the

possibility to achieve good levels of primary

stability using Axelmed® Paradigma® dental

implants that respect bone tissue biology and

surrounding structures.

The implant thread design (trapezoidal with

decreasing depth) and the conical shape of the

body allowed to achieve a good primary stability.

This is the main objective for the clinicians

dealing with immediate loading protocol during

their activity.

Effectively, this implant design appears to

demonstrate in almost 84% of the cases an

excellent primary stability with > 35 Ncm

torque insertion.

Post-Extraction sites

24,7%

55,9%

Maxillary

Torque(Ncm)

70

Implantsnumber

35

0

52

17

< 20 20 < 35 35 < 50 > 50

life from titanium

11

primary stability of Axelmed® Paradigma®

Lazzari P. * Private Practice, Milan, Italy

Dr. Piero Lazzari • Chief Scientific Adviser • Milano

Post extraction implant placement with immediate loading

Zirconia Full-Arch implant supported rehabilitation with

Axelmed® Paradigma® implants


12

Post extraction implant placement with delay loading

Full mouth rehabilitation implants Overdenture using

ball-attachment system



13

Courtesy of Dr. Luigi Bernardini • Fermo • Italy

Courtesy of Dr. Daniele Camerucci • Rome • Italy

14

Rehabilitation of edentolous maxilla in combination with

GBR technique

Placement of four implants in intraforaminal region using

autogenous bone as a graft material

Courtesy of Dr. Salvatore Terlizzi • Gravina • Italy

Courtesy of Dr. Davide Casella • Milan • Italy

15

Axelmed® Paradigma® implant placement in combination with

bone graft and vertical sinus lift (Summer’s Technique)

Axelmed® Paradigma® implant placement in posterior Maxilla

16

Axelmed®

Abutments

Together, the combi-

ned application of

platform switching

and concave design for

the emergence profile,

represent the way to

increase the amount

of soft tissue around

implants and to pro-

mote:

• elimination of exces-

sive abutment pressu-

re on gingival tissue

adjacent to implants;

• sufficient interproxi-

mal space between

implant and adjacent

tooth/implant for the

entry of interproximal

toothbrush;

• elimination of exces-

sive soft tissue blan-

ching during abutment

seating at prosthesis

delivery.

Grooves to easily cut

the extended external

lenght (9 mm)

to augment cement

retention and as

coded-system to

identify the emergence

profile diameter

Flat surface

for “closed tray implant

impression technique

Prosthetic

Emergence Profile

Round internal angle

for zirconia restorations

Platform Switching

to preserve marginal

bone level

life from titanium

17

The same Emergence Profile between abutments and

healing abutments

Number of grooves indicate the diameter of the emergence profile

4 mm5 mm

6 mm

18

Bone Regeneration Drill

Autologous bone, thanks to its

capacity of osteogenesis, oste-

oinduction and osteoconduction

is, nowadays, the gold standard

in bone regeneration.

Axelmed® Bone Regeneration

Drill (BRD) allows for the

collection of autologous bone

chips during the osteotomy for

the preparation of the implant

sites and to perform small GBR

(Guided Bone Regeneration)

procedure without recourse to

heterologous/homologous graft.

This means:

• lower risk of post-operative

complications;

• financial savings;

Enlargement for universal

depth stop

Hole for the collection of

autologous bone

Excellent cutting power

Apical shrinkage

to improve primary stability

19

Easy Surgical TrayA focused, ergonomic, not superflous kit.

Easy opening and storage.Axelmed Pack

®

20

A Healing Screw • B Closure Screw • C Paradigma® Implant

1 Lab Screw • 2 Lab Analog • 3 Calcinable Abutment

4 Esthetic Abutment • 5 Plastic Impression Transfer • 6 Definitive Screw

1

A

4

2

B

5

3

C

6

ALL-in-ONEAxel-

®

life from titanium

21

A way to solve 80% of cases by ordering just 1 code

(more efficient, more precise, more convenient)

ALL-in-ONE kit includes all the

components for the procedure

Immediate loading

Cement

Retained

Cement

Retained

Cement

Retained

Cement

Retained

Screw

Retained

Screw

Retained

Screw

Retained

Screw

Retained

Delayed loading

Temporary Crown

Temporary Crown

Temporary Crown

Definitive Crown

Definitive Crown

Definitive Crown

22

Kit ALL-in-ONE

Description Ø

Bulk Packaging

Q.ty

3,4

3,4

3,4

3,4

3,8

3,8

3,8

3,8

4,3

4,3

4,3

4,3

4,3

5,0

5,0

5,0

5,0

5,0

5,6

5,6

5,6

200

500

800

Height

Description

9mm

11mm

13mm

15mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

assorted All-in One KIT



Code

Code

81104

81105

81106

81107

81108

81109

81110

81111

81112

81113

81114

81115

81116

81117

81118

81119

81120

81121

81122

81123

81124

BA200

BA500

BA800

Axelmed Paradigma

implant system

ALL-in-ONE Kit contains 1x

• Paradigma® Implant

• Titanium closure cap

• Titanium healing cap*

• Plastic transfer (closed tray technique)

• 0° Esthetic abutment transmucosal h 1,8 mm*

• Definitive abutment screw gold-colour

• Plastic castable abutment

• Implant laboratory analog

• Laboratory abutment screw blue-colour

(*size vary with implant diameter)

ALL-in-ONE Kit sample

3

(choice of sizes)

® ®

23

Paradigma® Implant with closure cap and healing cap

Description 7mm 9mm 11mm 13mm 15mm Height

9mm

11mm

13mm

15mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

13mm

15mm

7mm

9mm

11mm

Code

82104

82105

82106

82107

82108

82109

82110

82111

82112

82113

82114

82115

82116

82117

82118

82119

82120

82121

82122

82123

82124

Paradigma®

Implant Ø 3,4

Paradigma®

Implant Ø 3,8

Paradigma®

Implant Ø 4,3

Paradigma®

Implant Ø 5,0

Paradigma®

Implant Ø 5,6

Ø 4mm emergenceprofile Healing Cap





Paradigma® implants scale 1:1.5

3

3

3

3

Bulk Packaging

Q.ty

200

500

800

Description

assorted Implants

assorted Implants

assorted Implants

Code

BS200

BS500

BS800(choice of sizes)

24

Healing Cap

Description Emergence profile Height Code

Closure Cap

Healing Cap

Healing Cap

Healing Cap

Ø 5mm

Ø 6mm

0mm

3mm

5mm

7mm

3mm

5mm

7mm

3mm

5mm

7mm

-

4,0

4,0

4,0

5,0

5,0

5,0

6,0

6,0

6,0

82001

82002

82003

82004

82005

82006

82007

82008

82009

82010

life from titanium

25

02

Impression components

Description Code

Implant abutment analog

Engaging transfer with Short screw

Engaging transfer with Long screw

Plastic extension tube for transfer

(10 pcs)

Plastic transfer (closed tray technique)

83001

83003

83004

83005

83006

26

Temporary Abutment

Description Code

Non-Hexed temporary abutment

with blue screw

Hexed temporary abutment

with blue screw

Non-Hexed plastic castable abutment

with blue screw

Hexed plastic castable abutment

with blue screw

Dental laboratory abutment screw

(blue-colour)

83007

83008

83009

83010

83019

life from titanium

0° Esthetic

abutment

with gold screw

0° Esthetic

abutment

with gold screw

15° Esthetic

abutment

with gold screw

30° Esthetic

abutment

with gold screw

Universal connector base

with gold screw

Definitive abutment screw

(gold-colour)

27

Definitive Abutment

Description Transmucosal h Profile Ø Code

4

5

6

4

5

6

5

5

5

5

-

-

1,8mm

1,8mm

1,8mm

2,8mm

2,8mm

2,8mm

1,8mm

2,8mm

1,8mm

2,8mm

-

-

83011

83012

83013

83014

83015

83016

83020

83021

83022

83023

83017

83018

28

Multi-Unit components

Description Height Profile Ø Code

0° Multi-Unit screwable

17° Multi-Unit with screw

30° Multi-Unit with screw

Laboratory analog for

Multi-Unit abutment

Non-Hexed transfer for

Multi-Unit abutment

Titanium Sleeve

for Multi-Unit abutment

Castable Sleeve


Healing cup


Prosthetic screw for

Multi-Unit abutment (Sleeve)

Abutment screw for

Multi-Unit (Implant)

Screwdriver for 0°

Multi-Unit abutment

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

1,5mm

3,0mm

4,0mm

2,5mm

4,0mm

3,5mm

5,0mm

-

-

-

-

-

-

-

83024

83025

83026

83027

83046

83028

83047

83002

83045

83043

83044

82011

83029

83048

85019

life from titanium

29

Ball Abutments

Description Height Profile Ø Code

Ball Abutments

normo Ø 2.5mm

Elastic cap for Ball Abutment

Green • Very Elastic 350 gr. (6pcs.)


Yellow • Extra Soft 500 gr. (6pcs.)


Pink • Soft 900 gr. (6pcs.)


Clear • Standard 1300 gr. (6pcs.)


Black • Laboratory (6pcs.)

Metal Container

for Elastic cap (6 pcs.)

Metal Transfer

for Ball Abutment

Instrument for Ball Abutment

(double side: applicator + extractor)

Laboratory analog for

Ball Abutments

4,0

4,0

4,0

4,0

-

-

-

-

-

-

-

-

-

1mm

3mm

5mm

7mm

-

-

-

-

-

-

-

-

-

83031

83032

83033

83034

83035

83036

83037

83038

83039

83040

83041

83042

83030

30

Surgery Kit

Description

Description

SURGERY KIT COMPONENTS

SURGERY KIT

Complete Surgery Kit

Q.ty Code

Code

86001

Complete Surgery Kit

Empty Surgery Box

Surgical Organizer

Pilot Drill

Drill twisted 2,0 mm

Drill twisted 2,4 mm

Drill BRD 2,8 mm

Drill BRD 3,2 mm

Drill BRD 3,6 mm

Drill BDR 4,0 mm

Drill BDR 4,4 mm

Drill BDR 4,8 mm

Drill BDR 5,2 mm

Drill Cortical 3,4 mm





Drill extender

Drill stop 7 mm

Drill stop 9 mm

Drill stop 11 mm

Drill stop 13 mm

Drill stop 15 mm

Tissue Punch 3,4 mm

Tissue Punch 4,3 mm

Manual screwdriver Short

Manual screwdriver Medium

Manual screwdriver Long

Machine Implant driver Short

Machine Implant driver Long

Parallel pin

Implant Torque Wrench with Reverse

Manual Implant driver Short

Manual Implant driver Long

Implant distance indicator

Machine screwdriver Short

Machine screwdriver Long

Empty Surgery Box (Alluminium)

Surgical Organizer (Alluminium)

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

1

84001

84002

84003

84004

84005

84006

84007

84008

84009

84010

84011

84012

84013

84014

84015

84016

84017

84018

84019

84020

84021

85001

85002

85007

85008

85009

85010

85011

85013

85017

85015

85016

85018

85046

85047

86002

86003

life from titanium

31

Pilot Drill

Drill twisted

Drill BRD

Drill Cortical

Drill extender

Drill Stop

Surgery Drills

Description CodeHeight mm Ø mm

7 9 11 13 15

7 9 11 1315

84001

84002

84003

84004

84005

84006

84007

84008

84009

84010

84011

84012

84013

84014

84015

84016

84017

84018

84019

84020

84021

1,6

2,0

2,4

2,8

3,2

3,6

4,0

4,4

4,8

5,2

3,4

3,8

4,3

5,0

5,6

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

7

9

11

13

15

32

Tissue Punch

Manual screwdriver Short

Manual screwdriver Medium

Manual screwdriver Long

Machine screwdriver Short

Machine screwdriver Long

Machine Implant driver Short

Machine Implant driver Long

Manual Implant driver Short

Manual Implant driver Long

Surgery Instruments

Description CodeØ mm

85001

85002

85007

85008

85009

85046

85047

85010

85011

85015

85016

3,4

4,3

life from titanium

Parallel pin

Implant Distance Indicator

Implant Torque wrench

Implant Torque wrench with reverse (0-50 Ncm)

33

Surgery Instruments

CodeDescription

22 Ncm 42 Ncm

32 Ncm 50 Ncm

72 Ncm

85013

85018

85014

85017

Temporary Abutment

Abutment

Abutment

Closure

CapHealing Cap

Impression components

Impre

Diameter Ø

3,4

3,8

4,3

5,0

5,6

Height mm

9111315

9111315

79

111315

79

111315

79

11

Code

Implant All-in-One

Code

81104

81105

81106

81107

81108

81109

81110

81111

81112

81113

81114

81115

81116

81117

81118

81119

81120

81121

81122

81123

81124

83007

83006 83005

83024

83025

83026

83031

83032

83033

83034 83030

h 1,0

h 3,0

h 5,0

h 7,0

83027

83046

83028

83047

h 2,5

h 4,0

h 3,5

h 5,0

82104

82105

82106

82107

82108

82109

82110

82111

82112

82113

82114

82115

82116

82117

82118

81119

82120

82121

82122

82123

82124

Non-HexedTitanium

Closed traytechnique

Ball Abutment

PilotDrill

Ma

nu

al sc

rew

dri

ver

Tis

sue

Pu

nch

Ma

chin

e s

cre

wd

rive

r

Ma

chin

e im

pla

nt

dri

ver

Ma

nu

al

imp

lan

t d

rive

r

Pa

rall

el

pin

Drills twisted

17°0°

Ø 4 Ø 5 Ø 6

30°

82002

82003

8200484002

8400384001

85007 85008 85015 8501385046 8501085009 8501685047 85011

82001

82005

82006

82007

82008

82009

82010

h 3,0

h 5,0

h 7,0Ø 2,0Ø 2,4

Ø 1,6

h 3,0

h 5,0

h 7,0

h 3,0

h 5,0

h 7,0

83008

Hexed Titanium

17 30

504504

ed

85001

Ø 3,4

85002

Ø 4,3

Plastic extension tube

for transfer

(10 pcs.)

83009

Non-HexedPlastic Castable

paradigmaReference

Table

Laborfor Ba

34

ScrewsHealing cup Impression

components

ession comp.

Laboratory components



Multi Unit Components

Overdenture

Surgery Drills

Surgery Instruments

ScrewConnector

Esthetic Abutment

83001

83043 83044 83002

83019

8304882011 83029

8301883017

83011

83014

83012

83015

83020

83021

83013

83016

83022

83023

8303583036830378303883039

Gr Very Elastic 350 gr. (6pcs.)

Yell . (6pcs.)

. (6pcs.)

Cl 1300 gr. (6pcs.)

(6pcs.) 83041 8304283040

83003

83004long screw

short screw

83045

Scr

ew

Dri

ver

for

0°

Mu

lti U

nit

Ab

utm

en

t

Imp

lan

t D

ista

nce

Ind

ica

tor

Su

rge

ry K

it

Su

rgic

al

Org

an

ize

r

Drills BRD Drills Cortical Drill extender Drill Stop

Elastic Cap Metal Containerfor Elastic Cap 6pcs.)

Transfer for Ball Abutment

Implant analog

Titanium sleeve Castable Sleeve Lab analog

Lab AbutmentScrew

DefinitiveScrew

Universal Connector Base

0° 0°

0°

0°

0°

0°

0°

15° 15° 30°15°

30°30°

Engaging transfer

Non-Hexed Transfer

84004840058400684007840088400984010

8401184012840138401484015

86001 Complete

86002 Empty

84016

85019 85018 85014

N/cm

22

32

42

50

72

85017 86003

84017

84018

84019

84020

84021

Ø 2,8Ø 3,2Ø 3,6Ø 4,0Ø 4,4Ø 4,8Ø 5,2

Ø 3,4Ø 3,8Ø 4,3Ø 5,0Ø 5,6

h 7,0h 9,0h 11h 13h 15

0 15 30

401

Instruments for Ball Abutment

(double side: applicator + extractor)

83010

Ind

ica

tor

7 9 11 1315

83041

s.) Ball Abutment B

El tti 35000 83035

Implant Sleeve

(double side: pplicator + extractor)

t

a

7

HexedPlastic Castable

Imp

lan

t to

rqu

e w

ren

ch

Imp

lan

t to

rqu

e w

ren

ch

wit

h r

eve

rse

ratory analogall Abutments

35

Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4

7-9-11

7-9-11-13-15

7-9-11-13-15

9-11-13-15

9-11-13-15

CompatibleInternal HexStandard

Implantdiameter Drills Diameter

2.02.4 2.8 2.8

2.8 2.8 2.8

2.8 2.8 2.83.2

2.83.64.0 4.4 4.4

3.6 3.62.8 2.8

4.43.62.8

4.44.8 5.2

3.62.8

4.43.62.8

3.6 3.6

3.2 3.2

C1

C2

C3

C4

C5

2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

Drills Diameter

Sterile

Batch code

Catalogue number

Serial number

Re-use is not allowed

Do not resterilize

Manufacturer

Use by date

Manufacturing date CE logo Notified Boby ID Number

Non sterile

Do not expose to sunlight

Not to be used in case package is damaged

Read usage instructions

Caution, consult documents

Temperature limitation

Drills Diameter

Soft Bone(Type IV)

Medium Bone(Type II - III)

Hard Bone

ImplantDiameter

ProstheticConnection

Lenght (mm)

(Type I)

Type IV

Type III

Type II

Type I from 800 to 1200 rpm

from 400 to 800 rpm

from 250 to 650 rpm

from 250 to 650 rpm

Bone density Drilling speed (rpm)

Axelmed Paradigma® Implant

Healing Abutment

Abutment screw

Multi Unit screw

Ball Abutment

Max 60 Ncm

Max 10 Ncm

Max 32 Ncm

Max 15 Ncm

Max 32 Ncm

Component Torque Value

Symbols CEN/ISO and Legend:

Surgical Drill Protocol

Caution: Federal law restricts this deviceto sale by or on the order of a dentist

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16REF

RxOnly

xxxx

LOT

SN 17

36

GENERAL INFORMATIONSThe AXELMED® implant line can be used exclusively by qualified Doctors and Dentists. The AXELMED® products are CE certified medical devices (93/42/ EEC).

AXELMED® PARADIGMA® implant lines act as anchors for crowns, bridges or prostheses to the bone (both the upper and the lower jaw). They have an internal hexagonal connection, a conical body with two principle threads and are made of titanium Gr. 4 in accordance with the requirements of ISO 5832-2. AXELMED® PARADIGMA® implants are present in 5 different diameters with the same prosthetic connection (see the table below). The surface of the fixture is machined at the portion of the collar and micro-roughed at the level of the body by SAP treatment (sandblasting with Al2O fine-grit, double Acidification, double decontamination with Argon Plasma). The surgical positioning of the implant is at the crestal or subcrestal bone level. It is packaged in a titanium cylinder protected by two sealed sterile tubes and a cover and a healing screw are to be found in the same packaging. It is sterilized by Gamma Ray irradiation (min 25kGy) and it is “STERILE” *(io direi: *sterilization lasts)until expiration date.

SURGICAL DRILLS The BRD drill (Bone Regeneration Drill) is used for the preparation of the implant bed. It presents a cavity to collect the bone, it must be used with sterile physiological solutions within 45-46 °C and the collected bone should be saved through a sterile spatula.

It is recommended to follow the protocol for the preparation of the implant site and to respect the rotational speed in relation to the bone density (see the table below). It is recommended to replace the BRD drills after about twenty times. Packaging: “NOT STERILE”.

PROSTHETIC COMPONENTSThe prosthetic components AXELMED® are made of titanium (Gr.5) according to ISO 5832-2. They include a wide range of devices (rights abutments, angled abutments, castable abutments, etc…) useful for the realization of temporary and definitive prosthesis. The prosthetic procedure is complex and highly specialized, so the clinician must have completed appropriate training courses and any prosthetic procedure must be the result of a proper diagnostic evaluation. Incorrect procedures or the use of non-original prosthetic parts can cause loss of the implant and biological damage. Wrapping: “NOT STERILE”.

TORQUE WRENCH AXELMED® torque wrenches are designed for the manual installation of the implant and the prosthetic components through default values of torque (see the table below). Packaging: “NOT STERILE”.

INSTRUMENTSBefore use, the “NON STERILE” instruments should be cleaned with hot water, disinfected, rinsed with distilled water, dried and sterilized. Do not use acids or harsh chemicals. The recommended sterilization method is with Autoclave Class B steam cycle with a temperature lower than 134°C (273°F) for 30 minutes. Instruments with signs of wear shouldn’t be used. Keep products in a closed and dry environment at room temperature (15-35° C/ 59-95 ° F). The disposal of products after use must be performed in accordance with the regulations on special waste.

WARRANTYThe warranty covers all parts that have production flaws proven before their use. Damage from improper use or caused by the use of non-original components are not covered by warranty. Any requests for damages can never exceed the average product price.

CAUTION: These general guidelines do not replace the User Manual (IFU) product specifications, nor the Axelmed Surgical and Prosthetic Guide, both available on the website www.axelmed.com or upon request to your distributor. Each product bears the main information on the packaging (see

S. Giuliano (MI) / Italy. ISO 9001 and ISO 13485. FDA Registered Brand. Axelmed® and Paradigma® are registered trademarks. ©Copyright 2016 AXELMED SRL

Disclaimers

Axelmed® Dental Implant System components are medical devices under the 93/42/CEE directives. AXELMED Company is a certified company ISO 13485 and fulfills the requirements ISO 9001.

Paradigma® Line of dental implants are part of the Axelmed® Dental Implant System, a clinical proven range of implantolgy products, and may be used only with the Axelmed® original components and instruments. The use of non original products, made by third parties, such as implant clones, abutments, screws, drills, instruments, components, etc. in conjunction with the Axelmed® Dental Implants System will void any warranty.

The user of Axelmed® products is the only responsible for determining whether or not any product is suitable for a patient. Axelmed® disclaims any liability and bears no responsibility for any direct/indirect damages, coming from or in connection with any practice errors in the use of Axelmed® products. The user is obliged to study the applications of Axelmed® products regularly.

The descriptions and explanations contained in this document are not sufficient for the proper use of the Axelmed® Dental Implant System. Professional knowledge of dental surgery, implantology and training in the handling of the Axelmed® Dental Implant System provided by a licensed and experienced operator, are always necessary. For detailed instructions please contact the local Axelmed® distributor/representative.

Amendments, errors and misprints may occur, as products are under continuous development. All items, product illustrations, texts, technical data, features, general contents, prices, etc. are intended only as examples and may vary without prior notice.

®Axelmed and ®Paradigma are registered marks of the AXELMED Company. *All the above mentioned names related to Companies and/or Products and/or Brands are only used for identification purposes. All the trademarks belong to their respective owners. The publication of the present catalogue supersedes and invalidates the previous versions.

©2016 AXELMED Company – All rights reserved. Reproductions, translations, storage and electronic processing are not permitted without prior written permission from AXELMED Company.

AXELMED S.R.L. Via della Liberazione, 5820098 S. Giuliano, Milan | Italy

0068

37

Main Features

Paradigma® Implant 04 SAP surface 08 Primary stability report 10 Clinical Cases 12 Axelmed® Abutments 16 BRD Drills and Packaging 18 ALL-in-ONE KIT 20

Catalogue

ALL-in-ONE 22 Single Implants 23 Healing Caps 24 Impression Components 25 Temporary Abutments 26 Definitive Abutments 27 Multi-Unit Components 28 Ball Abutments 29 Surgery Kit 30 Surgery Drills 31 Surgery Instruments 32 Reference Table 34 General Informations 36 Disclaimers 37

Index

38

life from titanium

Axelmed Clinical Center

In our dental clinic in Milan, we test all our products directly and we research for new solutions to

improve safety, features, ergonomics, aesthetics. All our implant line devices are studied, developed

and accurately tested in real clinical cases before production and release on market.

We put great care in the study of every single detail of our implant system and we test each compo-

nent every day to avoid the smallest complication to our fellow dentists. The Axelmed Dental Clinic is

also used as a training centre for our distributors’ specialists and clinicians.

In our dental laboratory, we have developed and tested all the prosthetic products of the Axelmed

Implant System. We take care of all the different aspects relevant to aesthetics and functionality of

functional prosthetic restorations following the entire rehabilitation process, from the impression to

the cementation.

In our internal cad-cam division, we use CAD design digital stations and CAM-CNC milling systems

and modern materials as zirconia, new bers and composites, etc. in association with the Axelmed

Abutments and prosthetic products.

Axelmed Dental Clinic

Axelmed Dental Laboratory

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AXELMED S.R.L. Via della Liberazione, 5820098 S. Giuliano, Milan | Italy

eMail: [email protected]: www.axelmed.com

Phone +39 02 9828 2694Call Free 800 144 347Fax +39 02 9828 5327

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