Anthogyr, Instructions For Use
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Instruction Manual for ANTHOGYR models including: 0459 Axiom Definitive Abutments, 0459, Axiom Definitive Abutments, Definitive Abutments, Abutments
Anthogyr, Instructions For Use
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DocumentDocumenten Instructions for use Axiom® definitive abutments
Validity Date: 2023-06
Anthogyr
www.anthogyr.com
REF: 063PROTH-UNIT_NOT
0459
2237 Av. André Lasquin
E-mail: contact@anthogyr.com
Index: C02
74700 Sallanches France
Phone: +33(0)4 50 58 02 37
SAP code: 707468
Axiom® definitive abutments
Instructions for use
Aesthetic impacted abutments
Axiom® 2.8
Aesthetic abutments
Axiom® BL Axiom® TL
Straight standard Angulated standard
abutments
abutments
Axiom® BL
Try-in abutments
Castable copings Protective caps
Axiom® BL Axiom® 2.8
Definitive prosthetic screw
Axiom® BL Axiom® TL
1. Product description
The Axiom® definitive abutments range includes definitive abutments, definitive prosthetic screws and associated prosthetic components which are try-in abutments, protective caps and castable copings. These instructions for use are valid for the following Axiom® components: ¬ Aesthetic impacted abutments ¬ Aesthetic abutments ¬ Straight standard abutments ¬ Angulated standard abutments ¬ Try-in abutments ¬ Protective caps ¬ Castable copings ¬ Definitive prosthetic screw
A definitive prosthetic screw is supplied with Aesthetic abutments, Straight standard abutments and Angulated standard abutments, in the same packaging.
Materials: Aesthetic impacted abutments, Aesthetic abutments, Straight standard abutments,Angulated standard abutments and screws are made of Titanium 6Aluminium-4Vanadium ELI alloy:
Chemical components Aluminium Vanadium Iron Oxygen Carbon Nitrogen Hydrogen Titanium
Composition, % (mass/mass) 5.50 to 6.50 3.50 to 4.50 0.25 0.13 0.08 0.05 0.012 Balance
Definitive prosthetic screws are DLC (Diamond-Like Carbon) coated. Protective caps are made of Polyetheretherketone (PEEK):
Chemical components Polyetheretherketone
Composition, % (mass/mass)
100
Try-in abutments are made of Titanium (Ti6Al4V ELI). Castable copings are made of Polymethylmethacrylate (PMMA).
2. Intended use
Axiom® definitive abutments are intended to be placed into Axiom® dental implants to provide support for cemented restorations. Prosthetic screws are intended to be placed into Axiom® BL or Axiom® TL dental implants to attach the restoration. Try-in abutments are intended to be temporarily positioned in dental implants to represent the definitive abutment geometry. Protective caps are intended to protect the coronary part of abutments during the healing phase. Castable copings are intended to prepare the restoration with casting technique and designed to fit the coronary parts of abutments.
3. Indications
Aesthetic impacted abutments are indicated to support definitive single-unit cemented restorations on Axiom® 2.8 dental implants. Axiom® BL and Axiom® TL aesthetic abutments are indicated to support definitive single-unit or multiple-unit cemented restorations on Axiom® BL or Axiom® TL dental implants respectively. Straight standard abutments are indicated to support definitive single-unit or multiple-unit cemented restorations on Axiom® BL dental implants. Angulated standard abutments are indicated to support definitive multiple-unit cemented restorations on Axiom® BL dental implants. Prosthetic screws are indicated to attach definitive restoration through an abutment on Axiom® dental implants. Axiom® TL prosthetic screw is also indicated to attach single-unit customized restoration on Axiom® TL dental implants. Protective caps are indicated to protect the coronary part of the abutment during healing process with abutment in place. Protective caps have a maximum duration of usage of 180 days.
Castable copings are indicated to support wax addition before casting of the definitive restoration for placement on abutments.
Axiom® BL
Aesthetic abutments Straight standard abutments Angulated standard abutments Axiom® 2.8
Aesthetic impacted abutments Axiom® TL
Aesthetic abutments Prosthetic screws for customized prosthesis
Indication
Singleunit
Multipleunit
·
·
·
·
·
·
·
·
·
4. Clinical benefits
The following clinical benefit concerns abutments and prosthetic screws. Restore function of a missing tooth: be biocompatible, withstand masticatory forces, and provide support for the prosthetic components.
5. Patient type and intended user
Aesthetic impacted abutments, aesthetic abutments, straight standard abutments, angulated standard abutments, protective caps, castable coping, try-in abutments and screws are intended for partially or totally edentulous adults requiring a single-unit and/or multiple-unit tooth restoration and who do not present any of the conditions mentioned in the "Contraindications" section. These components must be used by a surgeon and/ or a dental laboratory technician trained in dental implantology.
6. Contraindications
Allergy or hypersensitivity to chemical components in the materials used and mentioned in the "Product description" section.
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7. Warning
Implant surgery is a complex dental procedure. Incorrect techniques can cause implant failure and/or loss of bone support. Appropriate training and qualification as well as a good knowledge of surgical techniques with Anthogyr products are required. Anthogyr offers specific trainings.
8. Caution / Precaution
Clinical use: ¬ Single-use devices: do not reuse or re-sterilise. Risk
of contamination and risk of alteration of the functional surfaces. ¬ It is important to perform a pre-clinical assessment and treatment plan that takes into account the anatomical constraints of the future restoration. ¬ The definitive prosthetic component must be screwed or impacted on a sufficiently stable implant. ¬ During cement process, take care to remove any excess cement. ¬ As far as possible, the prosthetic components must be firmly fastened to avoid the inhalation or swallowing of components during intraoral use. ¬ The prosthetic components must not be tightened with a contra-angle. ¬ Do not use a prosthetic part after the expiry date indicated on the packaging.
Component rework: Aesthetic impacted abutments can be reworked only in the coronary portion in case where the impression is taken at the implant level. Aesthetic abutments can be reworked only in the coronary portion. Other components must not be reworked. The emergence profile must not be altered in order to maintain the original smooth surface. Improper modification can induce mechanical weakening.
Safety information regarding magnetic resonance imaging (MRI): This section is only applicable to implantable components: Non-clinical testing and MRI simulations were performed by Institut Straumann AG to evaluate the Anthogyr Dental Implant System. Non-clinical testing demonstrates that these products are MR Conditional. A patient with an Anthogyr Dental Implant System products can be scanned safely in an MR system under the following conditions: ¬ Static magnetic field of 1.5 Tesla and 3 Tesla only ¬ Maximum spatial gradient magnetic field of
4,000 gauss/cm (40 T/m) ¬ Maximum MR system reported whole body aver-
aged specific absorption rate (SAR) of 2 W/kg and head average SAR of 3.2 W/kg, for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode The scanning conditions defined above will produce a maximum temperature increase of 4.9 °C in implants from the Anthogyr Dental Implant Systems after 15 minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by implants from an Anthogyr Dental Implant System extends approximately 10 mm from this device when imaged with a gradient echo pulse sequence and a 3 Tesla MR system.
9. 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® definitive abutments, Protective caps, Try-in abutments, Castable copings and screws and may lead to additional dental treatment at the dental practice:
Residual risks: ¬ additional treatment at dentist's office ¬ bite/mastication/phonetic problems ¬ bone damage ¬ damage to adjacent/opposing tooth ¬ discomfort ¬ hyperplasia ¬ hypersensitivity/allergic reaction ¬ implant fracture ¬ injuries of gingiva ¬ irritation/inflammation ¬ local or systemic infection (including peri-
implantitis, periodontitis, gingivitis, fistula) ¬ local pain ¬ longer recovery/healing time than expected ¬ loss of implant ¬ loss of prosthetic component ¬ poor aesthetic outcome ¬ possibility of prolongation of surgery ¬ possibility of surgical implant explantation ¬ possibility to swallow/inhale small parts during the
procedure ¬ recall to the dentist's office
Side effects: ¬ swelling ¬ local inflammation ¬ bruising ¬ resorption of maxillary/mandibular ridge bone ¬ local infection ¬ minor bleeding
10. 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 information, please refer to the manuals listed in the "Further information" section.
IMPLANT
ABUTMENT
SECONDARY PART
Type of implant Type of connection Type of abutment
Compatible instrument
Compatible castable coping
Compatible protective cap
Axiom® 2.8
Conical
Aesthetic impacted abutments
Prehensive wrench (OPOP028) AND Impaction tip
+ SAFE LOCK®
OPCA028
OPPC028
Aesthetic abutments
-
-
Axiom® BL
Conical
Straight standard abutments
Axiom® BL abutment gripper
(INEXPS/INEXPL)
OPCA30X OPCA40X OPCA50X OPCA60X OPCR30X OPCR40X OPCR50X OPCR60X
OPPC30X OPPC40X OPPC40X OPPC60X
Angulated standard abutments
OPCR30X OPCR40X OPCR50X OPCR60X
Axiom® TL
Indexed M1.6 connection (flat)
Customised abutment
-
-
-
Aesthetic abutments
-
-
-
SCREW
Screw reference
Compatible instrument
-
-
OPTS160
Hexagonal instruments
TS160
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11. Cleaning and decontamination
Sterile components:
Anthogyr sterile prosthetic components are supplied
sterile (GAMMA sterilisation) in blue packaging and
are identified with a
logo. They are intended
for single use. Do not clean or sterilise the prosthetic
components. Cleaning, decontamination and sterilisa-
tion can compromise the essential material and design
features of the prosthetic components and result in
device failure.
Non-sterile components: Anthogyr non-sterile prosthetic components are supplied in white packaging and are identified with a
logo. Before treatment, remove the components from their packaging. Do not use the components if the packaging is opened or damaged. They must be cleaned and decontaminated before use and after each use for reusable components. Anthogyr recommends following the protocol described in the "cleaning and sterilisation" manual available at ifu.anthogyr.com or on request from Anthogyr at the above address. For sterilisation, see the "Sterilisation" section.
12. Sterilisation
Sterile components: For sterile prosthetic components, check that the entire packaging of the device is undamaged before opening. Prosthetic components with a damaged packaging must not be used. It is recommended to have a replacement component readily available for use. The intact blister pack protects the sterilised prosthetic component against any external influence and, if stored properly, guarantees sterility until the expiry date. The blister pack must not be opened before use of the prosthetic component. When removing the prosthetic component from the sterile packaging, asepsis rules must be followed. Anthogyr declines all responsibility for re-sterilised components, regardless of who carried out the re-sterilisation or the method used. Under no circumstances should a previously used or non-sterile prosthetic component be placed in the patient's mouth. If the original packaging is damaged, Anthogyr will not accept the return of the content.
Non-sterile components: Anthogyr prosthetic components delivered nonsterile must be sterilised before use. Anthogyr recommends following the protocol described in the cleaning and sterilisation manual available at ifu.anthogyr.com or on request from Anthogyr at the above address. After the sterilisation was done, asepsis rules must be followed.
13. Protocol for use
Refer to the brochures listed in the "Further information" section for detailed step-by-step instructions.
A. PROTOCOL FOR AESTHETIC ABUTMENTS
Axiom® 2.8
Step 1: Choose the right abutment using try-in abutment ¬ Clean and sterilise (See § Cleaning and decontamination and § Sterilisation) the try-in abutments. ¬ Use the prehensive wrench for try-in abutment installation in mouth: 1. Insert the abutment in the wrench aligning the arrow marked on the wrench with the flat ledge of the abutment. 2. Place the abutment into the implant: ¬ To place the flat spot in the vestibular area, use the arrow to identify the flat spot. ¬ To place the flat spot in the lingual area, use the point (located at 180° of the arrow) to identify the flat spot (if not visible in the mouth). 3. Press the button on the wrench to release the abutment. ¬ Place and remove different try-in abutments into the implant to find the most suitable one. ¬ Choose the reference of the impacted abutment according to the try-in abutment selected. Step 2: Place the aesthetic impacted abutment ¬ Remove the abutment from the sterile packaging on the sterile field. ¬ Before placing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant. ¬ Using the prehensive wrench, secure the abutment before transporting it in the patient mouth: follow the same steps as in "Step 1: Choose the right abutment". ¬ Before impaction of the definitive restoration in mouth, make a local anaesthesia if necessary. ¬ Select the impaction tip which is adapted to the abutment: ¬ In case of installation of a prosthesis cemented
inside of the mouth, use one of the 2 adapted impaction tips, depending on the angulation of the abutment. For 15 and 23° angulated abutments, position the laser marking of the tip on the flat surface of the abutment. ¬ In case of installation of a prosthesis cemented outside of the mouth, use the impaction tip adapted to the incisors to secure the prosthesis in the implant. For effective transmission of the impaction force, place the impaction tip firmly against the incisor edge of the prosthesis and as close to the implant axis as possible. ¬ Position the flat ledge of the abutment in the vestibule (or in the lingual surface in the case of straight abutments) using the prehensive wrench. ¬ Tighten the impaction tip on the SAFE LOCK®, adjust the motor speed to 10 000 rpm maximum. ¬ Position the tip on the abutment or the prosthesis as close to the implant axis as possible to maximise the axial force. ¬ Press the pedal and wait for 5 strokes.
¬ Do not try to remove an impacted abutment: risk of movement of the implant. Step 3: Protect the abutment during healing phase
¬ Clean and sterilise (See § Cleaning and decontamination and §Sterilisation) the protective cap.
¬ Clean the abutment 's coronary part thoroughly. ¬ Seal the protective cap onto the abutment using
temporary cement. Step 4: Place the restoration onto the abutment ¬ Use the castable coping as support for making the wax crown on the master model. ¬ Make the metallic crown according to current casting and finishing protocols. ¬ Remove the protective cap. ¬ Cement the crown onto the abutment.
Axiom® BL Step 1: Choose the right abutment using try-in abutments ¬ Clean and sterilise (See §Cleaning and decontamination and §Sterilisation) the try-in abutments. ¬ Secure the try-in abutments before transporting it in the patient mouth. ¬ Place and remove different try-in abutments into the implant to find the most suitable one. ¬ Choose the reference of the definitive abutment according to the try-in abutment selected. Step 2: Place the aesthetic abutment ¬ Clean and sterilise (See §Cleaning and decontamination and §Sterilisation) the abutment and the definitive screw. ¬ Before screwing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant. ¬ Place the abutment into the implant with Axiom® BL abutment gripper if needed. ¬ Tighten the definitive screw to 25 Ncm with a hexagonal wrench and the prosthetic dynamometric wrench or with a hexagonal mandrel and the TORQ CONTROL®. ¬ Close the screw channel. Over-tightening the abutment can deteriorate the implant connection and/or break the abutment. Insufficient tightening of the abutment may result in the abutment falling into the patient's mouth. Step 3: Place the standard abutment ¬ Cement the restoration onto the abutment.
Axiom® TL Step 1: Place the aesthetic abutment ¬ Clean and sterilise (See §Cleaning and decontamination and §Sterilisation) the abutment and the definitive screw. ¬ Before screwing the abutment, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant. ¬ Place the abutment into the implant.
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¬ Tighten the definitive screw to 25 Ncm with a hexagonal wrench and the prosthetic dynamometric wrench or with a hexagonal mandrel and the TORQ CONTROL®.
¬ Close the screw channel. Over-tightening the abutment can deteriorate the implant connection and/or break the abutment. Insufficient tightening of the abutment may result in the abutment falling into the patient's mouth.
Step 2: Place the restoration onto the aesthetic abutment ¬ Cement the restoration onto the abutment.
B. STANDARD ABUTMENTS Standard abutments are delivered sterile so can be placed just after implant placement.
Step 1: Place the standard abutment ¬ Before screwing the abutment, ensure that the
connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant. ¬ Place the abutment into the implant with Axiom® BL abutment gripper if needed. ¬ Tighten the definitive screw to 25 Ncm with a hexagonal wrench and the prosthetic dynamometric wrench or with a hexagonal mandrel and the TORQ CONTROL®. ¬ Close the screw channel. Over-tightening the abutment can deteriorate the implant connection and/or break the screw. Insufficient tightening of the abutment may result in the abutment falling into the patient's mouth. Step 2: Protect the standard abutment during healing phase ¬ Clean and sterilise (See §Cleaning and decontamination and §Sterilisation) the protective cap. ¬ Clean the abutment's coronary part thoroughly. ¬ Seal the protective cap onto the abutment's coronary part using temporary cement. Step 3: Place the restoration onto the standard abutment ¬ Use the castable coping as support for making the wax restoration on the master model: ¬ Use indexed castable coping for single-unit
restoration. ¬ Use non-indexed castable coping for multiple-unit
restoration. ¬ Make the metallic restoration according to current
casting and finishing protocols. ¬ Remove the protective cap. ¬ Cement the restoration onto the abutment.
C. PROSTHETIC SCREW FOR CUSTOMISED PROSTHESIS
Axiom® TL Protocol for definitive screws ¬ Clean and sterilise (See §Cleaning and decontamination and §Sterilisation) the prosthesis and the definitive screw. ¬ Before screwing the prosthesis, ensure that the connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant.
¬ Place the prosthesis into the implant. ¬ Tighten the definitive screw to 25 Ncm with a hexag-
onal wrench and the prosthetic dynamometric wrench or with a hexagonal mandrel and the TORQ CONTROL®. ¬ Close the screw channel. Over-tightening the screw can deteriorate the implant connection and/or break the abutment. Insufficient tightening of the abutment may result in the abutment falling into the patient's mouth.
14. Healing phase
The healing period required for osseointegration varies considerably and depends on the individual patient and treatment. It is the sole responsibility of the surgeon to decide when the implant can be loaded. The protective caps must be placed in sub-occlusion.
15. Lifespan of products
The Try-in abutments can be reprocessed 250 times, except in case of signs of deterioration (illegibility of markings or markers, signs of corrosion, etc.).
16. 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® definitive abutments, please refer to: ¬ Axiom® 2.8 user guide (AXIOM2-8_NOT)
Search code on ifu.anthogyr.com: OPAT211 ¬ Axiom® Multi Level® Prosthetic user guide
(AXIOM-MLP_NOT) Search code on ifu.anthogyr.com: OPAT400 ¬ Cleaning and Sterilisation user guide (NETT-STE_NOT) Search code on ifu.anthogyr.com: TS160 Subject to the availability of the European Medical Device Database (EUDAMED), the summary of safety and clinical performance characteristics (SSCP) is available at https://ec.europa.eu/tools/eudamed. Until EUDAMED is fully functional, the SSCP can be requested to Anthogyr at the following address: clinical@anthogyr.com.
Product Type Aesthetic abutments Aesthetic impacted abutments Axiom 2.8 Protective Cap Axiom® Protective cap Straight standard abutments Angulated standard abutments Prosthetic Screw
Basic UDI-DI 36633940107QV 36633940106QT 36633940108QX 36633940006QN
36633940105QR
36633940110QJ
17. 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.
18. Waste treatment
Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.
19. Information to be provided to the patient
Information on contraindications, warnings, precautions, side effects and complications with Anthogyr devices should be provided to the patient. The patient must be informed about MRI compatibility regarding the Anthogyr product used. Patients must accept regular medical follow-ups and should consult their doctor in the event of any unexpected change in the performance of the prosthetic reconstitution. Patients must be informed of the need to ensure regular oral hygiene. Patient must be advised to remain cautious for the first few weeks after surgery.
Traceability information is available to patients via the detachable labels on the device.
20. 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.
21. 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.
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22. Availability
Some components of the Anthogyr implant system are unavailable in certain countries.
23. 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
SN
Catalogue number NF EN ISO 15223-1
Batch code
NF EN ISO 15223-1
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
NF EN ISO 15223-1
inside
Sterilised using irradiation
NF EN ISO 15223-1
Do not resterilise NF EN ISO 15223-1
Symbol
Description of symbol
Source of symbol
Screwing torque
Anthogyr
Axiom® 2.8 straight impacted abutment
Anthogyr
Axiom® 2.8 angulated impacted Anthogyr abutment
Axiom® BL straight aesthetic abutment + Anthogyr prosthetic screw
Axiom® BL angulated aesthetic abutment + Anthogyr prosthetic screw
Axiom® TL straight aesthetic abutment + Anthogyr prosthetic screw
Axiom® TL angulated aesthetic abutment + Anthogyr prosthetic screw
Axiom® BL straight standard abutment + Anthogyr prosthetic screw
Axiom® BL angulated standard abutment + Anthogyr prosthetic screw
Axiom® protective cap
Anthogyr
Axiom® M1.6 prosthetic screw
Anthogyr
Non-sterile
NF EN ISO 15223-1
Sterilisable in a steam steriliser (autoclave) at temperature specified
Non sterilisable in a steam steriliser (autoclave) at temperature specified
Do not use if packaging is damaged and consult instructions for use
ISO 7000 - 2868 Anthogyr NF EN ISO 15223-1
Keep away from sunlight
NF EN ISO 15223-1
Do not re-use
NF EN ISO 15223-1
Caution
NF EN ISO 15223-1
Contains hazardous substances
NF EN ISO 15223-1
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