Anthogyr 063CICAT Healing Components Instruction Manual

: June 12, 2024
: Anthogyr

Anthogyr 063CICAT Healing Components

Anthogyr-063CICAT-Healing-Components-fig-1

Product Information

The Anthogyr prosthetic range includes healing components designed to protect the implant connection during the healing phase. These components are available in various shapes and sizes to meet the specific needs of every patient. The composition of these components includes chemical components like Aluminium, Vanadium, Iron, Oxygen, Carbon, Nitrogen, Hydrogen, and Titanium. The cover components are intended to protect the inner configuration of the implant after oral implantation and stabilize the soft tissue during the healing phase. The healing components are intended to protect the inner configuration of the implant after oral implantation 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.

Product Usage Instructions

Product Description: The Anthogyr prosthetic range includes healing components designed to protect the implant connection during the healing phase. These components are available in various shapes and sizes to meet the specific needs of every patient. The cover components are intended to protect the inner configuration of the implant after oral implantation and stabilize the soft tissue during the healing phase. The healing components are intended to protect the inner configuration of the implant after oral implantation and maintain, stabilize, and form the soft tissue during the healing phase.
Intended Use: Cover components are intended to protect the inner configuration of the implant after oral implantation and stabilize the soft tissue during the healing phase. Healing components are intended to protect the inner configuration of the implant after oral implantation and maintain, stabilize, and form the soft tissue during the healing phase.
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 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 described in these instructions for use have a maximum duration of usage of 180 days.
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.
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:
- Single-use devices: do not reuse or re-sterilize.
- 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 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 artifacts 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.

Product description

Anthogyr-063CICAT-Healing-Components-fig-2

The Anthogyr prosthetic range includes healing com-ponents 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	Composition, % (mass / mass)
Aluminium	5.50 to 6.50
Vanadium	3.50 to 4.50
Iron	≤ 0.25
Oxygen	≤ 0.13
Carbon	≤ 0.08
Nitrogen	≤ 0.05
Hydrogen	≤ 0.012
Titanium	Balance

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

Chemical components	Composition, % (mass / mass)
Polyetheretherketone	100

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 in-ner configuration of the implant after oral implanta-tion and maintain, stabilise and form the soft tissue during the healing phase.

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.

Patient type and intended user

Healing components are intended for adults requir-ing 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.

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. In-correct 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 assess-ment and treatment plan that takes into account the anatomical constraints of the future resto-ration.
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 swal-lowing 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 evalu-ated in the magnetic resonance (MR) environment. They have not been tested for heat build-up, migra-tion 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.

Residuals risks and side effects

The clinical outcome of dental treatment is influ-enced 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

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

implant

| Type of connection| Compatible

components

| Compatible

instruments

---|---|---|---

Axiom® Bone Level

|

Conical

| Axiom® BL cover screw Axiom® BL healing screw|

Axiom® manual surgical wrench OPCS100

Axiom® Tissue Level

|

InLink®

| Axiom® TL cover screw Axiom® TL healing screw

Axiom® 2.8

|

Conical

| Axiom® 2.8 cover plug| Axiom® 2.8

OPCF100

Axiom® 2.8 healing plug| Axiom® 2.8 OPCF100 or OPOP028

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.

Sterilisation

Anthogyr healing components are supplied sterile. Check that the entire packaging of the device is un-damaged 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 pro-tects 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 com-ponent. 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 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 informa-tion” 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.

Healing phase

Healing components must be placed in sub-occlu-sion.

Further information

For more information on the use of Anthogyr prod-ucts, please contact your local Anthogyr sales rep-resentative or contact Anthogyr customer service or visit ifu.anthogyr.com and www.anthogyr.com. For more specific information on the healing com-ponents, please refer to:
- Axiom® Multi Level® surgical user guide
  (AXIOM-MLC_NOT)
- Axiom® 2.8 surgical user guide (AXIOM2-8_NOT)
Subject to the availability of the European Medical Device Database (EUDAMED), the summary of safe-ty 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| Basic UDI-DI
---|---
Axiom® BL healing components| 36633940003QG
Axiom® TL healing components| 36633940003QG
Axiom® 2.8 healing components| 36633940004QJ

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.

Waste treatment

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

Patient information

Patients must accept regular medical follow-ups and should consult their doctor in the event of any unex-pected 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 knowl-edge 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 instruc-tions 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 prod-uct in question. In the event of a serious incident, the user must file a report with the local Anthogyr organisation 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.

Anthogyr-063CICAT-Healing-Components-fig-4