Anthogyr 063CICAT Healing and Cover Components Instructions

: June 1, 2024
: Anthogyr

Table of Contents

Anthogyr 063CICAT Healing and Cover Components
Product Information
Product Usage Instructions
Healing and cover components
Compatibility information
Cleaning and decontamination
Further information
Storage
Information to be provided to the patient
Symbols
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Anthogyr 063CICAT Healing and Cover Components

Product Information

Specifications

Validity Date: 2023-06
Brand: Anthogyr
Website: www.anthogyr.com
REF: 063CICAT _NOT 0459
Email: [email protected]
Phone: +33(0)4 50 58 02 37
SAP code: 707461

Product Usage Instructions

Product Description
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.
Intended Use
Cover components are intended to protect the inner configuration of the implant and stabilize the soft tissue during the healing phase.
Healing components are intended to protect the inner configuration of the implant and maintain, stabilize, and form the soft tissue during the healing phase.
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 stabilize 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. All components have a maximum duration of usage of 180 days.
Patient Type and Intended User
Healing and cover components are intended for adults requiring tooth restoration and who do not present any contraindications. They must be used by a surgeon trained in dental implantology.
Contraindications
Allergy or hypersensitivity to chemical components in the materials used is a contraindication.
Warning
Implant surgery is complex, and appropriate training, qualification, and knowledge of surgical techniques with Anthogyr products are required to prevent implant failure or bone loss. Specific training is offered by Anthogyr.

Caution/Precautions

Single-use devices: do not reuse or re-sterilize.
Perform a pre-clinical assessment considering anatomical constraints.
Healing screws or plugs must be fixed securely on a stable implant.
Firmly fasten prosthetic parts to avoid inhalation or swallowing during use.
Do not tighten components with a dynamometric wrench or contra-angle.
Do not use components after the expiry date.
No reworking of components allowed.

FAQ

Can the healing and cover components be reused?
No, these components are single-use devices and should not be reused or re- sterilized.
What should I do if I am allergic to any of the chemical components?
If you are allergic or hypersensitive to any of the chemical components mentioned, you should not use these components.
Is specific training required for using Anthogyr products?
Yes, appropriate training and qualification are necessary for using Anthogyr products to prevent implant failure or complications.

Instructions for use – Healing and cover components

Anthogyr
2237 Av. André Lasquin 74700 Sallanches – France
www.anthogyr.com
E-mail: [email protected] Phone: +33(0)4 50 58 02 37
Validity Date : 2023-06 REF: 063CICAT _NOT Index: D
SAP code: 707461

Healing and cover components

Instructions for use

Product Description

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 and healing screw Titanium-6Aluminium-4Vanadium ELI alloy:

Chemical components Composition, % (mass/mass)

Axiom® 2.8: cover plug and healing plug Polyetheretherketone (PEEK):

Chemical components Composition, % (mass/mass)

Polye the retherket one| 100

Intended use
Cover components are intended to protect the inner configuration of the implant and stabilize the soft tissue during the healing phase.
Healing components are intended to protect the in-ner configuration of the implant and maintain, stabilize and form the soft tissue during the healing phase.

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.
All components described in these instructions for use have a maximum duration of usage of 180 days.

Patient type and intended user
Healing and cover components are intended for adults requiring a single-unit or multiple-unit tooth restoration and who do not present any of the condi- tions listed among the “contraindications” sections. Healing and cover components must be used by a surgeon trained in dental implantology.

Contraindications
Allergy or hypersensitivity to chemical components in the materials used and mentioned in the “Product description” section.

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.

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 contra-angle.
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 healing and cover 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 Condition-al. 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 im-plants 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.

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 the 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

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 implant| Type of connection| Compatible components| Compatible instruments
---|---|---|---
Axiom® Bone Level| Conical| Axiom® BL cover screw Axiom® BL healing screw| For the placement of the cover or healing screws: OPCS100
| |
Axiom® Tissue Level| InLink®| Axiom® TL cover screw Axiom® TL healing screw| For the removal of the cover or healing screws: OPCS100 or INCHECV or INCHELV or INCHEXLV
| | Axiom® 2.8 cover plug|

OPCF100

Cleaning and decontamination

Anthogyr sterile healing and cover components are supplied sterile (GAMMA sterilisation) in blue pack-aging and are identified with a logo. They are intended for single use. Do not clean or sterilise the prosthetic components. Cleaning, decontamination and sterilization can compromise the essential material and design features of the prosthetic components and result in device failure.

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 blis-ter 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-sterilized components, regardless of who carried out the re-sterilization or the method used. Under no circumstances should a previously used or non-sterile pros-thetic component be placed in the patient’s mouth. If the original packaging is damaged, Anthogyr will not accept the return of the content.

Protocol for use
Refer to the brochures listed in the “Further information” section for detailed step-by-step instructions.

Step 1 : Removing the healing or cover 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 2 : Placement and removal 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.
Before placing the healing component, ensure that the 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 N.cm, without forcing the cover/healing screw in the implant.
Suture above the cover screw or around the healing screw to begin the integration period.
After the integration period, connect a hexagonal wrench to the cover/healing screw.
Manually 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.
Before placing the healing component, ensure that the 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 N.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 a hexagonal wrench to the cover/healing screw.
Manually 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.
Before placing the healing component, ensure that the 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 integration 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.
Before placing the healing component, ensure that the 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 integration period.
After the integration period, thread the threaded gripper wrench OPCF100 into the healing plug.
Pull to remove it from the implant.

Healing phase
Healing components must be placed in sub-occlusion.
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.

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 heal-ing 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

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: [email protected].

Product Type Basic UDI-DI

Axiom® BL Cover Screw| 36633940103QM
Axiom® TL Cover Screw| 36633940104QP
Axiom® Healing Screw| 36633940102QK
Axiom® 2.8 healing components| 36633940004QJ

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.

Waste treatment
Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.

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.

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 organization and the appropriate competent authori-ty in accordance with local regulations. Anthogyr also offers an online complaint service in the countries concerned.

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.

Availability
Some components of the Anthogyr implant system are unavailable in certain countries.

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 prod-uct symbols.

$Anthogy-063CICAT-Healing-and-Cover-Components- $2$$ $Anthogy-063CICAT-Healing-and-Cover-Components- $3$$ $Anthogy-063CICAT-Healing-and-Cover- Components- $4$$