Anthogyr Axiom TL REG Dental Implant Instruction Manual

Axiom TL REG Dental Implant
Instruction Manual

Product description

Axiom® Tissue Level REG implants| Axiom® Tissue Level PX implants| Axiom® Tissue Level X3 implants
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Axiom® Tissue Level REG/PX/X3 (Axiom® TL REG/ PX/X3) implants are part of the Axiom® Multi Level® 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 components and ancillary instruments.
Axiom® Multi Level® implants are implants with a BCP (Biphasic Calcium Phosphate) sandblasted endosseous surface.
Axiom® Multi Level® dental implants can be used after extraction or after the loss of natural teeth to restore chewing function. The prosthetic restorations 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 stabilisati on of removable dentures or the fixation of single unit or multiple unit restorations.
Axiom® TL implants can be used in one-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 immediate 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: osseointegrate in the jawbone, be biocompatible, withstand masti catory forces and provide support for the prostheti c components.

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 conditi ons menti oned in the “Contraindications” section. m
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. 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/Precaution

Clinical use:
Single-use devices: do not reuse or re-sterilise. 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 aft er the expiry date indicated on the packaging.
Specific instruments are necessary for placement of PX implants in D1 bone. They are sold separately from Axiom® surgery kits and may not be available in all countries. Safety information regarding Magnetic Resonance Imaging (MRI):
The safety and compati bility of Anthogyr devices that remain in the pati ent’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 examinati on on a pati ent 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-implantitis, 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 compati ble with the implant connection are suitable for use. For more information, please refer to the manuals listed in the “Further information” section.

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 enti re 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 re-sterilised implants, regardless of who carried out the re-sterilisati on 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 information” 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 platf orm, as well as the number of implants to be used and their positi oning 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 overheati ng the bone can be reduced by using irrigati on.
Compatibility information table

Type of implant| Type of connection| Compatible components Compatible instruments
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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.
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. Unti ghten 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 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.

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 inserti ng the implant with the surgical ratchet wrench or universal surgical instrument, control of the ti ghtening 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 components.

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 components are used during the healing phase, they must be placed in sub-occlusion.

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 specifi c informati on 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‑TLX3_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, SSCP can be requested to Anthogyr at the following address: clinical@anthogyr.com.

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 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”), 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 organisati on 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 regulati ons. 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.

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: contact@anthogyr.com
Phone: +33(0)4 50 58 02 37| Validity Date: 2022-09
REF: 063IMPL-TL_NOT
SAP code: 707384 Index: B
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References

• Anthogyr, Instructions For Use

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