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Anthogyr, Instructions For Use
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Instruction Manual for ANTHOGYR models including: 063CICAT_NOT Healing and Cover Components, 063CICAT_NOT, Healing and Cover Components, Cover Components, Components
Anthogyr, Instructions For Use
File Info : application/pdf, 3 Pages, 1.03MB
DocumentDocumenten Instructions for use Healing and cover components
Validity Date: 2024-09
Anthogyr
www.anthogyr.com
REF: 063CICAT_NOT
0459
2237 Av. André Lasquin
E-mail: contact@anthogyr.com
Index: E01
74700 Sallanches France
Phone: +33(0)4 50 58 02 37
SAP code: 707461
Healing and cover components
Instructions for use
1. Product description
Cover components
Cover screw/plug
Healing components
Healing screw/plug
HealFit® SH Scannable
healing screws
Axiom® Bone Level
Axiom® Tissue Level
Axiom® 2.8
-
The Anthogyr prosthetic range includes healing and cover components. These components are inserted in the implants and are available in a variety of shapes and sizes to meet the specific needs of every patient.
Materials:
Axiom® BL/TL: cover screw, healing screw, and scannable healing screw 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
Scannable healing screws are partially coated with ZrN (Zirconium Nitride).
Axiom® 2.8: cover plug and healing plug Polyetheretherketone (PEEK):
Chemical components
Polyetheretherketone
Composition, % (mass/mass)
100
2. Intended use
Cover components are intended to protect the inner configuration of the implant and stabilize the soft tissue during the healing phase. Healing screws and Healing plugs are intended to protect the inner configuration of the implant and maintain, stabilise and form the soft tissue during the healing phase. Scannable healing screws (HealFit® SH) are intended to protect the inner configuration of the implant and maintain, stabilise and form the soft tissue during the healing phase. They are also intended for conventional and digital impression taking to allow computer assisted design of a single-unit restoration on an Axiom® TL or an Axiom® BL implant.
3. Indications
Healing and cover components are indicated to be placed in fully or partially edentulous patients after implant placement. Cover components protect the inner configuration of the implant and stabilise the soft tissue during the healing phase. Healing components protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing phase.
Specific indications:
Scannable healing screws are only indicated for singleunit restorations. All healing and cover components described in these instructions for use have a maximum duration of usage of 180 days.
4. Patient type and intended user
Healing and cover components are intended for adults requiring a single-unit or multiple-unit tooth restoration, except scannable healing screws which are only intended for adults requiring single-unit tooth restoration. These devices must be used only in patients who do not present any of the conditions listed among the "contraindications" sections. Healing and cover components must be used by a surgeon trained in dental implantology.
5. Contraindications
Allergy or hypersensitivity to chemical components in the materials used and mentioned in the "Product description" section.
6. Warning
Implant surgery is a complex dental procedure. Incorrect techniques can cause implant failure and / or loss of bone support. Appropriate training and qualification and a good knowledge of surgical techniques with Anthogyr products are required. Anthogyr offers specific training.
7. Caution/Precautions
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 healing screws or healing plugs must be fixed on a sufficiently stable implant.
¬ As far as possible, the prosthetic parts must be firmly fastened to avoid the inhalation or swallowing of parts during intraoral use.
¬ The healing and cover components must not be tightened with a dynamometric wrench or a rotating power instrument.
¬ Axiom® 2.8 healing and cover components must not be impacted.
¬ Do not use a healing and cover component after the expiry date indicated on the packaging.
Component rework:
All components must not be reworked in any way.
Safety information regarding magnetic resonance imaging (MRI): 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 product 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 averaged
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.
8. 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 healing and cover components 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
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en Instructions for use Healing and cover components
¬ bruising ¬ resorption of maxillary / mandibular ridge bone ¬ local infection ¬ minor bleeding
9. 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. The healing and cover component choice depends on the planned final restoration. To ensure the best fit, and for more information, please refer to the manuals listed in the "Further information" section.
Type of Type of Compatible Compatible implant connection components instruments
Axiom® Bone Level
Axiom® Tissue Level
Conical InLink®
Axiom® BL cover screw Axiom® BL healing screw HealFit® SH BL scannable healing screw
Axiom® TL cover screw Axiom® TL healing screw HealFit® SH TL scannable healing screw
For the placement of the cover or healing screws: OPCS100
For the removal of the cover or healing screws: OPCS100 or INCHECV or INCHELV or INCHEXLV
Axiom® 2.8 cover plug
OPCF100
Axiom® 2.8 Conical
Axiom® 2.8 healing plug
For the placement of the healing plug: OPCF100 or OPOP028
For the removal of the healing plug: OPCF100
10. Cleaning and decontamination
Anthogyr sterile healing and cover 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
sterilisation can compromise the essential material and
design features of the prosthetic components and result
in device failure.
11. Sterilisation
Anthogyr healing and cover components are supplied sterile. 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 resterilisation 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.
12. Protocol for use
Refer to the brochures listed in the "Further information" section for detailed step-by-step instructions.
A. Axiom® BL and Axiom® TL cover and
healing screws
Step A.1: Removal of the component from the packaging ¬ Select the appropriate healing or cover component
for the treatment. ¬ Remove the component from the sterile packaging
on the sterile field.
Step A.2: Placement and removal of the component ¬ Connect the manual surgical wrench OPCS100 to the
cover/healing screw. No other instrument must be used during this phase. ¬ Ensure that the instrument is sufficiently engaged in the healing component before placement. ¬ Before placing the healing component, ensure that the implant connection is free of any fluid or other substance that may compromise the proper fit of the healing component in the implant. ¬ Manually tighten <10 Ncm using the manual surgical wrench OPCS100, without forcing the cover/healing screw in the implant. ¬ Suture above the cover screw or around the healing screw to begin the healing phase. ¬ After the healing phase, connect a hexagonal wrench to the cover/healing screw. ¬ Manually unscrew it from the implant.
B. HealFit® SH scannable healing screws
Step B.1: Choice of the component The HealFit® SH choice can be done either with digital library or HealFit® SH height gauge. Please also refer to the user guide for more information on the recommended anatomical shape depending on tooth position, and for recommended compatibilities between HealFit® SH and Anthogyr titanium bases. Planification using digital libraries: ¬ Use implant planning software with the HealFit® SH
library to perform scannable healing screw planning.
Planification using height gauge: ¬ Clean and sterilise the height gauge (refer to Anthogyr
instruments IFU listed in the "Further information" section). ¬ Place the BL side or the TL side of the height gauge into the Axiom® BL or the Axiom® TL implant to determine the most suitable HealFit® SH height. The grooves on the gauge correspond to the available HealFit® heights and correspond to the limit of the gingiva to ensure a 1.5 mm overhang. ¬ Choose the reference of the most suitable HealFit® SH, taking care that the selected reference will exceed the gingiva by at least select 1.5 mm.
Step B.2: Removal of the component from the packaging ¬ Select the appropriate HealFit® SH for the treatment. ¬ Remove the components from the sterile packaging
on the sterile field.
Step B.3: Placement of the scannable healing screw on the implant
Axiom® BL scannable healing screw: Note: The body and the M1.6 screw are provided disassembled for HealFit® SH BL. ¬ Before placing the HealFit® SH, ensure that the implant
connection is free of any fluid or other substance that may compromise the proper fit of the HealFit® SH in the implant. ¬ Place the body of the HealFit® SH into the implant (with Axiom® BL abutment gripper INEXPS / INEXPL if needed), ensuring that the groove(s) located on the top surface of the HealFit® SH are orientated towards the vestibule. ¬ Connect the manual surgical wrench OPCS100 to the M1.6 screw of the HealFit® SH. No other instrument must be used during this phase. ¬ Ensure that the instrument is sufficiently engaged in the screw before placement. ¬ Place the M1.6 screw in the body of the HealFit® SH using the manual surgical wrench OPCS100. Note: The body and the M1.6 screw of the HealFit® SH BL can also be assembled out of the patient's mouth prior
to placement and transport together in patient mouth, taking care that the components do not fall when they are inserted in the patient mouth. ¬ Tighten the M1.6 screw of the HealFit® SH manually
(<10 Ncm) using the manual surgical wrench OPCS100, without forcing the healing screw in the implant. ¬ Suture around the HealFit® SH to begin the healing period, ensuring that the coronal part exceeds the soft tissue by at least 1.5 mm to allow future impression taking.
Axiom® TL scannable healing screw: Note: The body and the M1.6 screw are provided assembled for HealFit® SH TL. ¬ Before placing the HealFit® SH, ensure that the implant
connection is free of any fluid or other substance that may compromise the proper fit of the HealFit® SH in the implant. ¬ Connect the manual surgical wrench OPCS100 to the M1.6 screw of the HealFit® SH. ¬ Ensure that the instrument is sufficiently engaged in the screw before placement. ¬ Place the HealFit® SH into the implant using the manual surgical wrench OPCS100, ensuring that the groove(s) located on the top surface of the HealFit® SH are orientated towards the vestibule. ¬ Tighten the M1.6 screw of the HealFit® SH manually (<10 Ncm) using the manual surgical wrench OPCS100, without forcing the healing screw in the implant. ¬ Suture around the HealFit® SH to begin the healing period, ensuring that the coronal part exceeds the soft tissue by at least 1.5 mm to allow future impression taking.
Step B.4: Impression taking Note: The quality of the digital impression is the practitioner's responsibility. The design of the prosthesis will be based on the same digital impression, thereby determining the compliance and quality of the final prosthesis. If the HealFit® SH does not exceed the soft tissue by at least 1.5 mm, Anthogyr recommends removing the HealFit® SH and perform an impression taking on implant using a digital transfer to ensure a precise positioning of the implant during computer assisted design of the dental prosthesis. ¬ Ensure that the HealFit® SH is fully screwed into
the implant. If in doubt, take peri-apical radiographs perpendicular to the connections. ¬ Ensure that the coronal part exceeds the soft tissue by at least 1.5 mm. ¬ Ensure that the HealFit® identification system is free of any fluid or other substance that may compromise the scan quality. ¬ Perform impression taking without removing the HealFit® SH using an intra-oral scanner. If necessary, it is possible to perform a conventional impression taking directly on the HealFit® SH. Then, perform a digital impression of the plaster model using a laboratory scanner.
Step B.5: Design and manufacture of the restoration ¬ Design the prosthesis with dental design software.
¬ Manufacture the prosthesis.
Step B.6: Removal of the scannable healing screw from the implant After the healing phase: ¬ Connect a hexagonal wrench to the M1.6 screw of
the HealFit® SH. ¬ Manually unscrew the M1.6 screw from the implant
and remove the healing screw. ¬ If needed, the Axiom® BL abutment extractor INEXPS /
INEXPL can be used after full removal of the M1.6 screw to ease the removal of a HealFit® SH BL stuck in an Axiom® BL implant.
C. Axiom® 2.8 cover and healing plugs
Step C.1: Removal of the component from the packaging ¬ Select the appropriate healing or cover component
for the treatment. ¬ Remove the component from the sterile packaging
on the sterile field.
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Step C.2: Placement and removal of the component
Cover plug: ¬ Thread the threaded gripper wrench OPCF100 into
the cover plug. ¬ Ensure that the instrument is sufficiently engaged in
the healing component before placement. ¬ Before placing the healing component, ensure that
the implant connection is free of any fluid or other substance that may compromise the proper fit of the healing component in the implant. ¬ Insert the cover plug into the implant. ¬ Apply moderate hand pressure to secure it in the implant. ¬ Remove the threaded gripper wrench OPCF100 by rotating it counterclockwise. ¬ Suture above the cover plug to begin the healing phase. ¬ After the healing phase, thread the threaded gripper wrench OPCF100 into the cover plug. ¬ Pull to remove it from the implant. Healing plug: ¬ Thread the threaded gripper wrench OPCF100 into the healing plug or insert it into the prehensive wrench OPOP028. ¬ Ensure that the instrument is sufficiently engaged in the healing component before placement. ¬ Before placing the healing component, ensure that the implant connection is free of any fluid or other substance that may compromise the proper fit of the healing component in the implant. ¬ Insert the healing plug into the implant. ¬ Apply moderate hand pressure to secure it in the implant. ¬ Remove the threaded gripper wrench OPCF100 by rotating it counterclockwise or press the button on the prehensive wrench OPOP028 to release the healing plug. ¬ Suture around the healing plug to begin the healing phase. ¬ After the healing phase, thread the threaded gripper wrench OPCF100 into the healing plug. ¬ Pull to remove it from the implant.
13. Healing phase
Healing and cover components must be placed in subocclusion. 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.
14. 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 cover and healing components, please refer to: ¬ Axiom® Multi Level® surgical user guide
(AXIOM-MLC_NOT) Search code on ifu.anthogyr.com: OPIM100 ¬ Axiom® 2.8 surgical user guide (AXIOM2-8_NOT) Search code on ifu.anthogyr.com: OPIM028 For more specific information on the HealFit® SH, please refer to: ¬ HealFit® SH user guide (HEALFIT-SH_NOT) Search code on ifu.anthogyr.com: OPSHSC33 For more specific information on the HealFit® SH gauge, please refer to: ¬ Anthogyr instruments IFU (063INSTRU_NOT) Search code on ifu.anthogyr.com: OPJCSHS 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, SSCP can be requested to Anthogyr at the following address: clinical@anthogyr.com.
Product Type
Basic UDI-DI
Axiom® BL cover Screws
36633940103QM
Axiom® TL cover Screws
36633940104QP
Axiom® healing screws
36633940102QK
Axiom® 2.8 healing components
36633940004QJ
HealFit® SH scannable healing screws 36633940153R4
15. 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.
16. Waste treatment
Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.
17. 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.
18. 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.
19. 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.
20. Availability
Some components of the Anthogyr implant system are unavailable in certain countries.
21. 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 NF EN ISO 15223-1 instructions for use
Medical Device
NF EN ISO 15223-1
CE marking compliance with current regulations
Directive 93/42/CEE ------------ MDR (EU) 2017/745
U.S. federal law restricts
this device to sale by or on the order of a dental
21 CFR 801.109(b)(1)
professional
Use-by date
NF EN ISO 15223-1
Single sterile barrier system
Single sterile barrier system with protective packaging inside
Sterilised using irradiation
NF EN ISO 15223-1 NF EN ISO 15223-1 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 ISO 7000 - 2868
temperature specified
Non sterilisable in
a steam steriliser (autoclave) at
Anthogyr
temperature specified
Do not use if packaging
is damaged and consult NF EN ISO 15223-1
instructions for use
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
Screwing torque
Anthogyr
Axiom® BL cover screw Anthogyr
Axiom® BL cover screw Anthogyr
Axiom® TL cover screw Anthogyr
Axiom® 2.8 cover plug Anthogyr
Axiom® BL healing screw
Axiom® TL healing screw
Anthogyr Anthogyr
Axiom® 2.8 healing plug Anthogyr
Axiom® BL HealFit® SH scannable healing screw
Anthogyr
Axiom® TL HealFit® SH scannable healing screw
Anthogyr
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