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Anthogyr, Instructions For Use
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Instructions for Anthogyr models including: 0459, 0459 Axiom Laboratory Components, Axiom Laboratory Components, Laboratory Components
Anthogyr, Instructions For Use
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DocumentDocumenten Instructions for Use Axiom® laboratory components
Validity Date: 2023-09
Anthogyr
www.anthogyr.com
REF: 063LAB_NOT
0459
2237 Av. André Lasquin
E-mail: contact@anthogyr.com
Index: C
74700 Sallanches France
Phone: +33(0)4 50 58 02 37
SAP code: 707465
Axiom® laboratory components
Instructions for Use
1. Product description
Axiom® laboratory components include:
Laboratory screws/locks Wax-up supports (supplied with laboratory screw
in the same packaging)
AxIN® lab bases (supplied with laboratory screw
in the same packaging)
Connection protections Lab tools Lab kits
Materials: Laboratory screws and AxIN® lab bases are made of Titanium (Ti6Al4V ELI). Laboratory locks are made of Titanium (Ti6Al4V ELI) and Polyoxymethylene copolymer (POM-C). Connection protections are made of Titanium (Ti6Al4V ELI), Stainless steel and Polyoxymethylene copolymer (POM-C). Wax-up support are made of Polyetheretherketone (PEEK). Lab tools are made of Stainless steel and Titanium (Ti6Al4V ELI). All laboratory screws (except OPTS162), laboratory locks and clipped protective cap are made of anodized titanium.
2. Intended use
Axiom® laboratory components are intended to enable dental laboratory work to perform the prosthetic restoration after oral implantation.
Specific uses: Laboratory screws/locks are used during dental laboratory work to fix prosthetic components during the preparation of a restoration on models. Wax-up supports are used to prototype the shape of the desired prosthesis. AxIN® lab bases are used to represent the AxIN® base position on the master model as it is in patient's mouth. Connection protections are used to protect the restoration inner shape when the restoration is out of the master model. AxIN® lab tool is used to easily handle AxIN® bases or AxIN® lab bases. InLink® lab tools are used to assemble/disassemble the lock of an inLink® prosthesis. Lab kits are used to store laboratory components.
3. Indications
Axiom® laboratory components are part of Axiom® implant systems, the indications of which are given in the respective implant IFUs.
4. Patient type and intended user
Axiom® laboratory components are intended for use in dental laboratories by dental technicians.
5. Caution/Precaution
Laboratory locks should not be put in the oven. Excessive tightening of AxIN® lab screws reduces the number of reuses of the AxIN® lab bases.
Component rework: Axiom® laboratory components must not be reworked in any way except Wax-up supports.
6. Residual risks and side effects
The clinical outcome of dental treatment is influenced by multiple factors. The following residual risks and possible side effects are related to the use of Axiom® laboratory components and may lead to additional dental treatment at the dental practice:
Residual risks: additional treatment at dentist's office discomfort hypersensitivity/allergic reaction irritation/inflammation local or systemic infection (including peri-implan-
titis, periodontitis, gingivitis, fistula)
local pain longer recovery/healing time than expected poor aesthetic outcome possibility of prolongation of surgery recall to the dentist's office
Side effects: swelling local inflammation bruising resorption of maxillary/mandibular ridge bone local infection minor bleeding
7. Compatibility information
Anthogyr implants and prosthetic components are available in a wide variety of configurations. Only Anthogyr parts that are compatible with the implant connection are suitable for use. For more informa-
tion, please refer to the manuals listed in the "Further information" section.
Type of Axiom® laboratory component
System
Compatible instruments
Laboratory screws for straight screw channel
Axiom® BL
Axiom® TL Hexagonal wrench Multi-Unit
Laboratory screws for angulated screw channel
Axiom® TL Multi-Unit
AxIN®
Ball wrench
Laboratory locks
InLink® Ball wrench
Wax-up supports
Axiom® BL Multi-Unit
Hexagonal wrench
AxIN® lab bases Connection protections
AxIN® Multi-Unit
InLink®
Ball wrench Hexagonal wrench Hexagonal wrench + Ball wrench
Lab tools
AxIN® InLink®
Ball wrench
All references identified by "AA" are dedicated to
Angulated Access. All references identified by "-P" are dedicated to multiple-unit restoration.
8. Protocol for use
Refer to the brochures listed in the "Further informa-
tion" section for detailed step-by-step instructions.
Laboratory screws
On the model, tighten the laboratory screw(s) (manual torque, <10N.cm) in order to screw-retain the restoration on the analog(s).
Laboratory locks 1. Place 2 to 4 laboratory locks on the model and
choose the analogues with the least relative divergence. 2. Screw the laboratory locks in the analogues with a ball wrench, without compressing their elastic rings. 3. Position the prosthesis on the laboratory locks, ensuring it is properly placed. 4. Finish screwing in the lock with a ball wrench until the prosthesis feels tight. 5. Screw (manual torque, <10N.cm) the restoration on these laboratory locks with a ball wrench. Ensure good contact between the platforms.
Wax-up supports 1. On the model, place the wax-up on the analog and
tighten (manual torque, <10N.cm) its associated laboratory screw. 2. Rework the wax-up support and build the prosthetic project.
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en Instructions for Use Axiom® laboratory components
AxIN® lab bases 1. On the model obtained with the implant analog,
assemble the AxIN® lab base and its associated laboratory screw. 2. The resulting assembly allows the prosthesis to be assembled and disassembled easily throughout the finishing cycles. 3. Assemble the prosthesis on the AxIN® lab base and apply a very light manual tightening on the laboratory screw to hold the temporary prosthesis on the laboratory base.
9. Lifespan of products
The component can be reused in accordance with the maximum number of uses defined in the table
below, except in cases where there are signs of deterioration (illegibility of markings or markers, deterioration of the coating, signs of corrosion, etc.).
One use is equivalent to one reprocessing cycle.
Type of device Laboratory screws/locks AxIN® lab bases Connection protections
Product lifespan 5 years 100 uses 5 years
14. Validity
The publication of this document supersedes and replaces all previous versions. Anthogyr all rights reserved. Anthogyr® and/or other trademarks and logos of Anthogyr® mentioned herein are trademarks or registered trademarks of Anthogyr.
15. Availability
Some components of the Anthogyr implant system are unavailable in certain countries.
Connection protections On the prosthesis, place a connection protection on each connection. To secure the connection protection, hold it in place with a hexagonal wrench and screw across (manual torque, <10N.cm) the prosthesis with: a hexagonal wrench for Multi-Unit connection
protections
a ball wrench for inLink® connection protections.
AxIN® lab tool 1. Unscrew the tool ring. 2. Position the trilobe of the AxIN® lab base or the
AxIN® base in the tool clamp.
3. Tighten the tool ring to hold the base.
InLink® lab tools
2-in-1 tool (assembly + disassembly)
Assembly steps: use the "IN" part of the tool.
Remove the cap. Place the lock into the retention ring. Pay attention the mounting orientation of the
retention ring on the lock: the notches on the
ring must be placed on the tip side of the lock. Clip everything into the tool. The tool`s lugs must be placed in the notches
of the ring. Place the cap on the lock. Press the tool on the cap. Turn lightly to reveal the head of the lock. Push the lock in the prosthesis. Turn the inLink® wrench anticlockwise until it
stops. Remove the inLink® wrench. Apply pressure to control the proper placement
of the lock with the ball wrench.
Disassembly steps: use the "OUT" part of the tool.
Screw the lock in the inLink® wrench with the ball wrench.
Remove the lock by pulling and turning clockwise.
Unscrew the lock from the inLink® wrench with the ball wrench.
Disassembly tool
Screw the lock in the inLink® wrench with the ball wrench.
Remove the lock by pulling and turning clockwise.
Unscrew the lock from the inLink® wrench with the ball wrench.
10. Further information
For more information on the use of Anthogyr products, please contact your local Anthogyr sales representative or contact Anthogyr customer service or visit ifu.anthogyr.com and www.anthogyr.com. For more specific information on the Axiom® laboratory components, please refer to:
Axiom® Multi Level® Prosthetic user guide
(A X I O M-M L P_ N OT)
11. Storage
Store these products in a clean, dry area, at ambient temperature. Improper storage may compromise the essential characteristics of the materials and design, which may lead to device failure.
12. Waste treatment
Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.
13. Notes
The practitioner must have the necessary knowledge to practice dental implantology and must be familiar with the handling instructions for Anthogyr products as described in this document in order to use Anthogyr products safely and in accordance with their instructions for use. Anthogyr products must be used in accordance with the manufacturer's instructions for use. The dental surgeon is solely responsible for the proper use of Anthogyr products in accordance with their instructions for use and to determine whether the product is suitable for the individual patient's situation. Anthogyr products are part of a complete range and must be used in combination with the corresponding original components and instruments distributed by Anthogyr, its parent company and any affiliates or subsidiaries of the parent company ("Straumann"). The use of third-party products not distributed by Anthogyr voids any warranty or other obligation, express or implied, of Anthogyr. Any product-related issues must be reported to the local Anthogyr organisation together with the product in question. In the event of a serious incident, the user must file a report with the local Anthogyr organisation and the appropriate competent authority in accordance with local regulations. Anthogyr also offers an online complaint service in the countries concerned.
16. Symbols
The following table describes the symbols that may be printed on the packaging label. Please refer to the label on the packaging for the applicable product symbols.
Symbol Description of symbol Source of symbol
Manufacturer
NF EN ISO 15223-1
Date of manufacture
NF EN ISO 15223-1
Catalogue number
NF EN ISO 15223-1
Batch code
NF EN ISO 15223-1
SN
Serial number
NF EN ISO 15223-1
Consult instructions for
use or consult electronic instructions for use
NF EN ISO 15223-1
Medical Device
NF EN ISO 15223-1
CE marking - compliance with current regulations
U.S. federal law restricts this device to sale by or on the order of a dental professional
Directive 93/42/CEE ------------ MDR (EU) 2017/745
21 CFR 801.109(b)(1)
Use-by date
NF EN ISO 15223-1
Single sterile barrier system
NF EN ISO 15223-1
Single sterile barrier system with protective
packaging inside
NF EN ISO 15223-1
Sterilised using irradiation NF EN ISO 15223-1
Do not resterilise
NF EN ISO 15223-1
Non-sterile
NF EN ISO 15223-1
Sterilisable in a steam
steriliser (autoclave) at temperature specified
ISO 7000 - 2868
Non sterilisable in a steam
steriliser (autoclave) at temperature specified
Anthogyr
Do not use if packaging
is damaged and consult instructions for use
NF EN ISO 15223-1
Keep away from sunlight NF EN ISO 15223-1
Do not re-use Caution
NF EN ISO 15223-1 NF EN ISO 15223-1
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Symbol Description of symbol Source of symbol
Contains hazardous substances
NF EN ISO 15223-1
Screwing torque
Anthogyr
Axiom® BL AxIN® laboratory base + AxIN® laboratory screw
Anthogyr
Axiom® TL AxIN® laboratory base + AxIN® laboratory screw
Anthogyr
Axiom® M1.6 laboratory screw
Anthogyr
Axiom® M1.6 long laboratory screw
Multi-Unit M1.4 laboratory screw
Anthogyr Anthogyr
Axiom® BL Waxup + laboratory screw
Anthogyr
Axiom® BL Waxup + laboratory screws (long and short)
Anthogyr
Axiom® Multi-Unit Waxup + laboratory screw Anthogyr
Axiom® Multi-Unit
Waxup + laboratory
Anthogyr
screws (long and short)
en Instructions for Use Axiom® laboratory components
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