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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
Dr. Piero Lazzari • Chief Scientific Adviser • Milano
12
Post extraction implant placement with delay loading
Full mouth rehabilitation implants Overdenture using
ball-attachment system
Dr. Piero Lazzari • Chief Scientific Adviser • Milano
Dr. Piero Lazzari • Chief Scientific Adviser • Milano
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
assorted All-in One KIT
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
Ø 4mm emergenceprofile Healing Cap
Ø 5mm emergenceprofile Healing Cap
Ø 6mm emergenceprofile Healing Cap
Ø 6mm 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
for Multi-Unit abutment
Healing cup
for Multi-Unit abutment
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.)
Elastic cap for Ball Abutment
Yellow • Extra Soft 500 gr. (6pcs.)
Elastic cap for Ball Abutment
Pink • Soft 900 gr. (6pcs.)
Elastic cap for Ball Abutment
Clear • Standard 1300 gr. (6pcs.)
Elastic cap for Ball Abutment
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 Cortical 3,8 mm
Drill Cortical 4,3 mm
Drill Cortical 5,0 mm
Drill Cortical 5,6 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
Laboratory components
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
39
paradigma
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r. E
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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
®