Anthogyr, Instructions For Use
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Instruction Manual for Anthogyr models including: 063CICAT_NOT, 063CICAT, 063CICAT Healing Components, Healing Components, Components
1/3 en – Instructions for Use – Healing components 0459 Anthogyr 2237 Av. André Lasquin 74700 Sallanches – France www.anthogyr.com E-mail: contact@anthogyr.com
Anthogyr, Instructions For Use
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DocumentDocumenten Instructions for Use Healing components
Anthogyr
www.anthogyr.com
Validity Date : 2022-02
0459
2237 Av. André Lasquin
E-mail: contact@anthogyr.com
REF: 063CICAT _NOT
74700 Sallanches France
Phone: +33(0)4 50 58 02 37
Index: C
Healing components Instructions for Use
1. Product description
Cover screw/plug Healing screw/plug Axiom® Bone Level
Axiom® Tissue Level
Axiom® 2.8
The Anthogyr prosthetic range includes healing components to protect the implant connection during healing phase. These components are offered in a variety of shapes and sizes to meet the specific needs of every patient.
Materials: Axiom® BL/TL: cover screw and 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
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 after oral implantation and stabilise the soft tissue during the healing phase.
Healing components are intended to protect the inner configuration of the implant after oral implantation and maintain, stabilise and form the soft tissue
during the healing phase.
3. Indications
Healing 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, stabilise and form the soft tissue during the healing phase. All components described in these instructions for use have a maximum duration of usage of 180 days.
4. Patient type and intended user
Healing components are intended for adults requiring a single-unit or multiple-unit tooth restoration and who do not present any of the conditions listed among the "Contraindications" sections. Healing 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 assess-
ment and treatment plan that takes into account the anatomical constraints of the future restoration.
The permanent prosthetic component 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.
Do not use a prosthetic part after the expiry date
indicated on the packaging.
Component rework: Healing components must not be reworked in any way.
Safety information regarding magnetic resonance imaging (MRI): The safety and compatibility of Anthogyr devices that remain in the patient's body have not been evaluated in the magnetic resonance (MR) environment. They have not been tested for heat build-up, migration or artefacts in MR environments. The safety of Anthogyr devices in an MR environment is unknown. Performing an MRI examination on a patient wearing such a device may result in injury.
8. Residuals 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 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-implan-
titis, 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
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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. For more information, please refer to the manuals listed in the "Further information" section.
Type of implant Axiom® Bone Level
Axiom® Tissue Level
Axiom® 2.8
Type of connection Conical
InLink®
Conical
Compatible Compatible components instruments
Axiom® BL cover screw Axiom® BL Axiom® healing screw manual
surgical Axiom® TL wrench cover screw OPCS100 Axiom® TL healing screw
Axiom® 2.8 Axiom® 2.8 cover plug OPCF100
Axiom® 2.8 healing plug
Axiom® 2.8 OPCF100 or
OPOP028
10. Cleaning and disinfection
Anthogyr sterile healing 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, disinfection and sterilisation
can compromise the essential material and design
features of the prosthetic components and result
in device failure.
11. Sterilisation
Anthogyr healing 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 re-sterilisation or the method used. Under no circum-
stances 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.
Step 1: Removing the healing component from the packaging Select the appropriate healing component for the treatment. Remove the healing component from the sterile packaging on the sterile field.
Step 2: Placement of the healing component
Axiom® BL
Cover screw and healing screw:
Connect the manual surgical wrench OPCS100 to
the cover/healing screw.
Ensure that the instrument is sufficiently engaged
in the healing component before placement.
Tighten manually <10N.cm, without forcing the
cover/healing screw in the implant.
Suture above the cover screw or around the heal-
ing screw to begin the integration period.
After the integration period, connect the manual
surgical wrench OPCS100 to the cover/healing
screw.
Unscrew it from the implant.
Axiom® TL
Cover screw and healing screw:
Connect the manual surgical wrench OPCS100 to
the cover/healing screw.
Ensure that the instrument is sufficiently engaged
in the healing component before placement.
Tighten manually <10N.cm, without forcing the
cover/healing screw in the implant.
Suture around the cover/healing screw to begin
the integration period.
After the integration period, connect the manual
surgical wrench OPCS100 to the cover/healing
screw.
Unscrew it from the implant.
Axiom® 2.8
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.
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 around the healing plug to begin the in-
tegration period.
After the integration period, 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 prehen-
sive wrench OPOP028.
Ensure that the instrument is sufficiently engaged
in the healing component before placement.
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 above or around the healing plug to begin
the integration period.
After the integration period, thread the threaded
gripper wrench OPCF100 into the healing plug.
Pull to remove it from the implant.
13. Healing phase
Healing components must be placed in sub-occlusion.
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 healing components, please refer to:
Axiom® Multi Level® surgical user guide
(A X I O M-M LC _ N OT)
Axiom® 2.8 surgical user guide (AXIOM2-8_NOT)
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 Axiom® BL healing components Axiom® TL healing components Axiom® 2.8 healing components
Basic UDI-DI 36633940003QG 36633940003QG 36633940004QJ
15. Storage
Store these products in a clean, dry area, at room 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. Patient information
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
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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
Symbol Description of symbol Source of symbol 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 Anthogyr temperature specified
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
NF EN ISO 15223-1
Caution
Contains hazardous substances
Screwing torque
NF EN ISO 15223-1 NF EN ISO 15223-1 Anthogyr
Axiom® BL cover screw Anthogyr
Axiom® TL cover screw Anthogyr
Axiom® 2.8 cover plug Anthogyr
Axiom® BL healing screw Anthogyr
Axiom® TL healing screw Anthogyr
Axiom® 2.8 healing plug Anthogyr
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
Directive 93/42/CEE
CE marking - compliance with current regulations
------------ MDR (EU) 2017/745
FDA certification logo
21 CFR 801.109(b)(1)
Use-by date
NF EN ISO 15223-1
Single sterile barrier system
Single sterile barrier system with protective packaging inside
NF EN ISO 15223-1 NF EN ISO 15223-1
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