Anthogyr Axiom TL REG-PX-X3 Implants Instruction Manual

Anthogyr Axiom TL REG-PX-X3 Implants

Product description

Axiom® Tissue Level REG/PX/X3 (Axiom® TL REG/PX/X3) implants are part of the Axiom® Multi Lev-el® system, an implant concept which offers a range of endosseous dental implants of various designs (length, diameter, thread profile, platform, etc.) and the corresponding prosthetic parts, healing compo-nents and ancillary instruments.
Axiom® Multi Level® implants are implants with a BCP (Biphasic Calcium Phosphate) sandblasted en-dosseous surface.
Axiom® Multi Level® dental implants can be used after extraction or after the loss of natural teeth to restore chewing function. The prosthetic resto- rations available include single crowns, bridges and partial or full arch dentures, which are connected to the implants via the corresponding abutments. These instructions for use apply to the following dental implants:

• Axiom® TL REG implants
• Axiom® TL PX implants
• Axiom® TL X3 implants

A cover screw is supplied with the implant and can be found in the cap of the implant tube.

Materials:
Titanium-6Aluminium-4Vanadium ELI alloy:

Intended use

Axiom® TL REG/PX/X3 implants are intended for oral implantation to replace missing tooth roots, and to provide support for dental restoration.

Indications
Axiom® TL implants are indicated for stabilisation of removable dentures or the fixation of single unit or multiple unit restorations.
Axiom® TL implants can be used in one-stage or two-stage surgeries in the upper and lower jaw of partially or fully edentulous patients to restore the function of a missing tooth. They can be placed with immedi-ate function in appropriate clinical situations (good primary stability and appropriate occlusal loading). Axiom® TL PX implants are designed to achieve good primary stability in soft bone. They are suitable for immediate or delayed implantation.
Axiom® TL X3 implants are designed for immediate use in suitable clinical situations (sufficient primary stability and appropriate occlusive loads).

Clinical benefits
Restore function of a missing tooth.

Patient type and intended user
Axiom® TL REG/PX/X3 implants are intended for use with partially or totally edentulous adult patients who do not present any of the conditions mentioned in the “Contraindications” section.
Axiom® TL REG/PX/X3 implants must be used by a surgeon trained in dental implantology.

Contraindications
Axiom® TL REG/PX/X3 implants are contraindicated in following cases:

• Allergy or hypersensitivity to chemical components in the materials used and mentioned in the “Product description” section.
• Absolute contraindications: serious diseases (tumours, heart disease, etc.), metabolism disorders, uncompensated haematologic diseases, drug addiction, alcoholism, psychosis, functional disorders, xerostomia, immune deficiency, leukocyte disorder, local or systemic treatments (steroid, anticoagulant, chemotherapy, or radiation therapy, etc.).
• Relative contraindications: bruxism, occlusal stress, parafunction, unfavourable bone anatomy, pregnancy, growth not finished, insufficient oral hygiene, smoking lack of motivation or cooperation, irradiated bone, uncontrolled periodontal disease, oral infections, or inflammations.
• Localised contraindications: Excessive resorption and/or insufficient bone quality, local radicular residues.

Specific contraindications:

Axiom® TL X3 implants with a 3.4 mm diameter are not suitable for single-unit tooth restorations in the posterior region.

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/Precaution

Clinical use:
Single-use devices: do not reuse or resterilise. Doing so increases the 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.
Do not use an implant after the expiry date indicated on the packaging.
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 An-thogyr devices in an MR environment is unknown. Performing an MRI examination on a patient wearing such a device may result in injuries.

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 Axiom® TL REG/PX/X3 and may lead to additional dental treatment at the dental practice:

Residual risks:

• additional treatment at dentist’s office
• bite/mastication/phonetic problems
• bone compression
• 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
• nerve damage possibly resulting in chronic pain
• paraesthesia, dysaesthesia
• 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
• sinus perforation

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.

Compatibility information table

Type of implant| Type of connection| Compatible components| Compatible instruments
---|---|---|---

Axiom® Tissue Level

| inLink®| inLink®|

Axiom® TL implant instruments (gold)

included in the surgical kit

M1.6

| Tissue Level
LOCATOR® (abutments) from ZEST DENTAL
Type of implant| Type of platform| Compatible components

Axiom® Tissue Level

|

Ø 4.0 mm/N

| Axiom® TL components identified by a “N” laser marked
Axiom® TL components pink

Ø 4.8 mm/R

| Axiom® TL components identified by a “R” laser marked
Axiom® TL components cyan

An Axiom® BL implant can be made compatible with an Axiom® TL implant through the use of an inLink® abutment.

Cleaning and disinfection
Axiom® TL REG/PX/X3 implants are supplied sterile (GAMMA sterilisation) and are intended for single use. Do not clean or sterilise the implants. Cleaning, disinfection and sterilisation can compromise the essential material and design features of the implants and result in device failure.

Sterilisation
Anthogyr dental implants are supplied sterile. Check that the entire packaging of the device is undamaged before opening. Implant with a damaged packaging must not be used. It is recommended to have a replacement implant readily available for use. The intact blister pack protects the sterilised implant against any external influence and, if stored properly, guarantees sterility until the expiry date. The blister pack must not be opened before implant use. When removing the implant from the sterile packaging, asepsis rules must be followed.
Anthogyr declines all responsibility for resterilised implants, regardless of who carried out the re-sterilisation or the method used. Under no circumstances should a previously used or non-sterile implant be implanted. 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: Preoperative planning
The type, diameter and length of the implant, the diameter and the height of the platform, as well as the number of implants to be used and their positioning must be determined in advance, taking into account the patient’s anatomy and the oral environment. For this purpose, use the X-ray templates available in the range or a digital library.

Step 2: Preparation of the implant site

1. Mark the site with a pointer drill or a round bur.
2. Each site should be prepared using a progressive sequence of drilling diameters in accordance with the implant diameter and the bone density. Make sure never to exceed the depth of the planned drilling: use of depth stops on each rotational instrument or use of drills with a stop or a contra-angle fitted with a stop system.

Please refer to the “step-by-step” guidelines listed in the “Further information” section. The practitioner must adapt the drilling/tapping sequences as best as possible to the clinical case (especially regarding the bone density).
Avoid overheating the bone when drilling and tightening the implant to reduce the risk of bone loss during the osteointegration phase. The risk of overheating the bone can be reduced by using irrigation.
Step 3: Removing the implant from the packaging
The implant is packaged in a cardboard box with sterile packaging consisting of a sealed blister pack and a capped tube.

• Remove the blister from the cardboard box outside of the sterile field.
• Open the seal without touching the inside of the blister.
• Let the capped tube gently fall on the sterile field.

Warning: All handling should be done so as to avoid direct contact with the exterior surface of the implant. When handling the implant, be very careful not to drop it in the patient’s mouth.
The implant is movable once the tube and cap have been opened. Make sure to keep the tube upright when handling, with the implant access pointing upward.

1. Open the packaging with one hand.
2. Use the corresponding implant wrench or mandrel to pick up the implant directly.
   a. Press the packaging on the indicated areas to immobilise the implant.
   b. Connect the implant tightening instrument into the implant.
   c. Ensure that the instrument is sufficiently engaged in the implant connection before removing it from the packaging. To do this, check that the first grey part is no longer visible.
   d. Release the packaging to free the implant.
   e. Remove the implant from the packaging.

REPLACE THE IMPLANT IN THE PACKAGING DURING SURGERY IF NECESSARY

1. Position the implant between the packaging sheets.
2. Press the packaging on the indicated areas to immobilise the implant.
3. Disconnect the implant tightening instrument from the implant.
4. Release the packaging.

Step 4: Insert the implant

PLACEMENT USING A CONTRA-ANGLE:

• Adjust the output speed of the contra-angle to the recommended speed of:
• 15 rpm for Axiom® TL PX
• 15 rpm for Axiom® TL X3
• 25 rpm for Axiom® TL REG
• Using the contra-angle, screw the implant into the channel to the desired depth. The Axiom® TL REG/PX/X3 surgical protocol provides for a 0.5 mm subcrestal positioning of the implant and 0.5 to 1 mm sub-gingival positioning of the implant. Implant wrenches and mandrels have markings for the vertical positioning of the implant relative to anatomical structures.
• In case of single-unit restoration, at the end of the screwing process, orient the implant trilobe as closely as possible in the appropriate direction,depending on the desired prosthetic restoration and the situation in the mouth. To do this, implant wrenches and mandrels have 3 sides, each of them represented by a visual mark on the instrument’s body.

Warning: Check the tightening torque frequently to make sure it does not exceed 80 N.cm. Untighten and retighten to reduce the screw pressure if needed.

MANUAL PLACEMENT:

Using the ratchet wrench (available in the kit):

• Manually pre-tighten the implant into the implant channel using the implant wrench or implant manual screw wrench.
• Assemble the surgical ratchet wrench.
• Screw the implant into the channel to the desired depth. The Axiom® TL REG/PX/X3 surgical protocol provides for a 0.5 mm subcrestal positioning of the implant. Implant wrenches have markings for the vertical positioning of the implant relative to anatomical structures.
• At the end of the screwing process, orient the im-plant trilobe as closely as possible in the appropriate direction, depending on the desired prosthetic restoration and the situation in the mouth. To do this, implant wrenches and mandrels have 3 sides, each of them represented by a visual mark on the instrument’s body.

Using the universal surgical instrument:
The universal surgical instrument can be used in the anterior maxillary area to control and guide the insertion of the Axiom® TL REG/PX/X3 implant along the implant axis.

• Remove the implant from the packaging using the trilobed tightening mandrel.
• Screw the implant into the channel to the desired depth. The Axiom® TL REG/PX/X3 surgical protocol provides for a 0.5 mm subcrestal positioning of the implant and 0.5 to 1 mm sub-gingival positioning of the implant. Implant wrenches and mandrels have markings for the vertical positioning of the implant relative to anatomical structures.
• In case of unitary restoration, at the end of the screwing process, orient the implant trilobe as closely as possible in the appropriate direction, depending on the desired prosthetic restoration and the situation in the mouth. To do this, implant wrenches and mandrels have 3 sides, each of them represented by a visual mark on the instrument’s body.

Warning: When inserting the implant with the surgical ratchet wrench or universal surgical instrument, control of the tightening torque is not possible. However, the verification of the torque using a surgical dynamometric wrench to tighten the implant is possible.
Too high of a torque can damage the connection. Untighten and retighten to reduce the screw pressure if needed.

Step 5: Soft tissue treatment, wound closure

• Select the appropriate healing component for the treatment.
• Refer to the instructions for use for healing com-ponents.

USE OF THE COVER SCREW:

• Remove the cover screw from the cap of the implant tube.
  1. Connect the manual surgical wrench to the screw.
  2. Pull to release the screw.
• Tighten manually < 10 N.cm, without forcing the cover screw in the implant.
• Suture above the cover screw to begin the integration period.

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. If temporary com-ponents are used during the healing phase, they must be placed in sub-occlusion.

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 Axiom® TL REG/PX/X3, please refer to:

• Axiom® TL REG/PX: Axiom® Multi Level® surgical user guide (AXIOM-MLC_NOT)
• Axiom® TL X3: Axiom® TL X3 surgical user guide (AXIOM-TX3C_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, SSCP can be re-quested to Anthogyr at the following address: [email protected].

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”), unless otherwise specified in these instructions for use. 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 product symbols.

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

| 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| Directive 93/42/CEE

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| NF EN ISO 15223-1
| Single sterile barrier system with protective packaging inside| NF EN ISO 15223-1
| 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 temperature specified| Anthogyr
| 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| NF EN ISO 15223-1
| Contains hazardous substances| NF EN ISO 15223-1
| Screwing torque| Anthogyr
| Axiom® TL REG Implant

+ Cover screw

| Anthogyr
| Axiom® TL PX Implant + Cover screw| Anthogyr
| Axiom® TL X3 Implant + Cover screw| Anthogyr

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: 2022-03
REF: 063IMPL-TL_NOT
Index: A

References

• Anthogyr, Instructions For Use

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