Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

K230104 · Anthogyr · DZE · Oct 16, 2023 · Dental

Device Facts

• Record ID: K230104
• Device Name: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
• Applicant: Anthogyr
• Product Code: DZE · Dental
• Decision Date: Oct 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the installation of the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion. Temporary components have a maximum duration of usage of 180 days. The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

Device Story

The Anthogyr AXIOM® BL X3 system consists of tapered endosseous dental implants and associated Multi-Unit prosthetic components. Implants are surgically placed in the maxilla or mandible by dental clinicians to serve as artificial roots. The system includes Multi-Unit abutments, protective caps, temporary copings, and Flexibase components to support bridges and bars. Implants feature a conical Morse taper connection with a tri-lobe interface. Components are connected to implants to provide a platform for prosthetic superstructures. The device is used in dental clinics; clinicians use the system to restore chewing function and aesthetics for edentulous or partially edentulous patients. The system supports both immediate and delayed loading protocols. Clinical benefit is derived from the restoration of oral function and tooth replacement. The device is provided sterile (gamma irradiation) or non-sterile (requiring autoclave sterilization by the end-user).

Clinical Evidence

Bench testing only. Performance was evaluated via dynamic fatigue testing per FDA guidance for root-form endosseous dental implants. Biocompatibility was confirmed via material equivalence and cytotoxicity testing (ISO 10993-5). Sterilization validation was performed per ISO 11137-1 (gamma) and ISO 17665-1 (moist heat). Bone-to-implant contact and pullout strength were compared to reference device K033922, demonstrating substantial equivalence.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Design: Tapered bone-level implants with conical Morse taper/tri-lobe interface. Surface: Sand-blasted and acid-etched (BCP). Sterilization: Gamma irradiation (SAL 10^-6) or steam autoclave. Connectivity: Mechanical connection to prosthetic components. Dimensions: Diameters 3.4mm to 6.4mm; lengths 6.5mm to 18mm.

Indications for Use

Indicated for patients requiring endosteal dental implants in the maxilla or mandible to support prosthetic devices (artificial teeth) for restoration of chewing function. Applicable for single or multiple-unit restorations, single or two-stage surgical procedures, and immediate loading when primary stability is achieved. Temporary components are indicated for soft tissue management during healing (max 180 days, non-occlusal). OPMUN0-0 abutments are restricted to maxillary lateral and mandibular central/lateral incisors.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• NUVO CF Implant System (K203309)

Reference Devices

• AXIOM® PX (K161177)
• Straumann BLX Implant System (K173961)
• Axiom® REG (K131066)
• ANTHOGYR DENTAL IMPLANT SYSTEMS: AXIOM (K101913)
• Medentika Multi-unit Abutments (K191123)
• Straumann® Screw-Retained Abutments (K192401)
• Straumann® Magellan Abutment System (K133421)
• Neodent Implant System – GM Narrow Implant System (K220251)
• Straumann® Modification to ITI Dental Implant System (K033922)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

Anthogyr % Jennifer Jackson Sr. Dir., Regulatory & Quality NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K230104

Trade/Device Name: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 15, 2023 Received: September 18, 2023

Dear Jennifer Jackson:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230104

Device Name Anthogyr AXIOM® BL X3 Implants

#### Indications for Use (Describe)

The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Indications for Use

510(k) Number (if known) K230104

Device Name

Anthogyr Multi-Unit components for AXIOM® BL

Indications for Use (Describe)

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

# 510(k) Summary

# Submitter's Contact Information

| Submitter: | Straumann USA, LLC | | | | | |
|---------------------|--------------------------------------------------------------------------------------|-----------------------------|--|--|--|--|
| | 60 Minuteman Road | | | | | |
| | Andover, MA 01810 | | | | | |
| | Registration No.: 1222315 | Owner/Operator No.: 9005052 | | | | |
| | On the behalf of: | | | | | |
| | Anthogyr | | | | | |
| | 2237 Av. André Lasquin, | | | | | |
| | 74700 Sallanches, France | | | | | |
| | Registration No.: 8020776 | Owner/Operator No.: 9005052 | | | | |
| | Jennifer M. Jackson, MS, RAC | | | | | |
| | Senior Director, Regulatory Affairs and Quality NAM<br>Phone Number: [phone] | | | | | |
| | Fax Number: [phone] | | | | | |
| Prepared By & | Aude GOULET/Estelle SALLE | | | | | |
| Alternate Contact: | Regulatory Affairs Project Manager | | | | | |
| | Anthogyr | | | | | |
| | Phone number: [phone] | | | | | |
| Date of Submission: | October 12, 2023 | | | | | |
| Name of the Device | | | | | | |

| Trade Names: | Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit<br>components for AXIOM® BL |
|--------------|------------------------------------------------------------------------------------|
| Common Name: | Endosseous dental implant |

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

| Classification Name: | Endosseous dental implant |
|------------------------|------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE, NHA |
| Classification Panel: | Dental |
| Proprietary Name: | Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit<br>components for AXIOM® BL |

### Predicate Device(s)

Primary Predicate:

- K203309 NUVO CF Implant System .
#### Reference Devices:

- . K161177 – AXIOM® PX
- K173961 Straumann BLX Implant System .
- K131066 Axiom® REG .
- . K101913 – ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM
- . K191123 – Medentika Multi-unit Abutments
- . K192401 – Straumann® Screw-Retained Abutments
- K133421 Straumann® Magellan Abutment System .
- . K220251 – Neodent Implant System – GM Narrow Implant System
- K033922 Straumann® Modification to ITI Dental Implant System .

### Device Description

#### Subject implants

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

### Subject prosthetic components

#### Anthogyr Multi-Unit abutments for AXIOM® BL

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

- Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
- Angulated Multi-Unit abutments with various gingival heights and angulations.

#### Anthogyr Multi-Unit protective caps

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

#### Anthogyr Multi-Unit temporary copings

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings can be used prior to the insertion of

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

### Anthoqyr Flexibase for Multi-Unit abutments

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

### Intended Use

### Subject implants

Anthogyr dental implants are suitable for endosteal implantation in the maxilla or mandible and for the functional and esthetic oral rehabilitation of patients with missing teeth.

### Subject prosthetic components

Anthogyr Multi-Unit abutments are intended to be placed into AXIOM® BL implants to provide support for multi-unit prosthetic reconstructions such as bridges and bars. Copings are fixed to the Multi-Unit abutments in order to provide support for prosthetic reconstructions such as bridges and bars.

### Indications for Use

#### Subject implants

The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

#### Subject prosthetic components

Anthogyr Multi-Unit prosthetic components directly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the installation of the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

### Technological Characteristics Comparison Tables

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:

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### Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL

510(k) Summary - K230104

| | SUBJECT DEVICE | PRIMARY<br>PREDICATE DEVICE | REFERENCE DEVICES | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURES | K230104 | K203309 | K161177 | K173961 | K131066 | K101913 | K033922 |
| | Anthogyr AXIOM® BL<br>X3 implants | NUVO CF Implant<br>System | AXIOM® PX | Straumann BLX<br>Implant System | Axiom® REG | Anthogyr Dental<br>Implant Systems:<br>AXIOM | Straumann®<br>Modification to ITI<br>Dental Implant<br>System |
| Indications for Use | The implant system is<br>intended to be<br>surgically placed in the<br>maxilla or mandible to<br>provide support for<br>prosthetic devices<br>such as artificial teeth<br>in order to restore<br>chewing function. It<br>may be used with<br>single-stage or two-<br>stage procedures, for<br>single or multiple unit<br>restorations, and may<br>be loaded immediately<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Multiple tooth<br>applications may be<br>rigidly splinted. | The Implant System is<br>intended to be<br>surgically placed in the<br>maxilla or mandible to<br>provide support for<br>prosthetic devices<br>such as artificial teeth<br>in order to restore<br>chewing function. It<br>may be used with<br>single-stage or two-<br>stage procedures, for<br>single or multiple unit<br>restorations, and may<br>be loaded immediately<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Multiple tooth<br>applications may be<br>rigidly splinted. | Anthogyr dental<br>implants are intended<br>for use as artificial root<br>structures for<br>replacement of<br>missing teeth. They<br>can be used for<br>stabilization of<br>removable prostheses<br>or fixation of single<br>tooth restorations or<br>partial dentures.<br>Anthogyr dental<br>systems are indicated<br>for one-stage or two-<br>stage surgery.It is up<br>to the practitioner to<br>decide whether<br>immediate or delayed<br>loading is most<br>appropriate, based on<br>clinical factors like<br>good primary stability<br>and appropriate<br>occlusal loading. | Straumann® BLX<br>Implants are suitable<br>for endosteal<br>implantation in the<br>upper and lower jaw<br>and for the functional<br>and esthetic oral<br>rehabilitation of<br>edentulous and<br>partially edentulous<br>patients. BLX Implants<br>can be placed with<br>immediate function on<br>single-tooth<br>applications when<br>good primary stability<br>is achieved and with<br>appropriate occlusal<br>loading to restore<br>chewing function. The<br>prosthetic restorations<br>are connected to the<br>implants through the<br>corresponding<br>abutment components. | Anthogyr AXIOM® REG<br>implants are intended<br>for use as artificial root<br>structures for<br>replacement of missing<br>teeth. They can be used<br>for stabilization of<br>removable prostheses<br>or fixation of single tooth<br>restorations or partial<br>dentures.<br>The Axiom dental<br>system is indicated for<br>one-stage or two-stage<br>surgery.<br>It is up to the<br>practitioner to decide<br>whether immediate or<br>delayed loading is most<br>appropriate, based on<br>clinical factors like good<br>primary stability and<br>appropriate occlusal<br>loading.<br>Prefabricated<br>components are<br>intended for use as<br>accessories to dental<br>implants to support<br>implant-supported<br>restorations. | Both Dental Implant<br>Systems are intended<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support of<br>single or multiple-unit<br>restorations including;<br>cement retained,<br>screw retained or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. | ITI implants are<br>intended for surgical<br>placement in the<br>maxillary and/or<br>mandibular arches to<br>provide support for<br>prosthetic restoration<br>in edentulous or<br>partially edentulous<br>patients. ITI Dental<br>Implants are for single-<br>stage or two-stage<br>surgery.<br>ITI Dental Implants are<br>intended for immediate<br>placement and<br>function on single-<br>tooth and/or multiple<br>tooth applications<br>when good primary<br>stability is achieved,<br>with appropriate<br>occlusal loading, in<br>order to restore<br>chewing function.<br>Multiple tooth<br>applications may be<br>rigidly splinted. In the<br>case of edentulous<br>patients, four or more<br>implants must be<br>used. |
| | SUBJECT DEVICE | PRIMARY<br>PREDICATE DEVICE | REFERENCE DEVICES | | | | |
| | K230104 | K203309 | K161177 | K173961 | K131066 | K101913 | K033922 |
| FEATURES | Anthogyr AXIOM® BL<br>X3 implants | NUVO CF Implant<br>System | AXIOM® PX | Straumann BLX<br>Implant System | Axiom® REG | Anthogyr Dental<br>Implant Systems:<br>AXIOM | Straumann®<br>Modification to ITI<br>Dental Implant<br>System |
| Implant type | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level | Tissue Level |
| Implant to Abutment<br>interface | 2.7 mm diameter<br>conical Morse taper<br>connection with tri-lobe | Internal Hex | 2.7 mm diameter<br>conical Morse taper<br>connection with tri-lobe | BLX (with conical<br>fitting) | 2,7 mm diameter<br>conical Morse taper<br>connection with tri-lobe | 2,7 mm diameter<br>conical Morse taper<br>connection with tri-lobe | Straumann® synOcta®<br>connection |
| Implant Diameter | Ø 3.4 mm, 4.0 mm, 4.6<br>mm, 5.2 mm, 5.8mm<br>and 6.4 mm | Ø 3.5 mm, 3.75 mm,<br>4.0, 4.3 mm and 5.0<br>mm | Ø 3.4 mm, 4.0 mm, 4.6<br>mm, and 5.2 mm | Ø 4.5 mm, 5.5 mm, 6.5<br>mm | Ø 3.4 mm and 4.0 mm | Ø 3.4 mm, 4.0 mm, 4.6<br>mm and 5.2 mm | Ø 3.3mm<br>Ø 4.1mm<br>Ø 4.8mm |
| Implant Length | Ø 3.4 mm : 8, 10, 12,<br>14, 16 and 18 mm<br>4.0 mm : 6.5, 8, 10,<br>12, 14, 16 and 18 mm<br>4.6 mm : 6.5, 8, 10, 12<br>and 14 mm<br>5.2 mm : 6.5, 8, 10<br>and 12 mm<br>5.8mm : 6.5, 8, 10 and<br>12 mm<br>6.4 mm : 6.5, 8, 10,12<br>mm | 3.5 mm: 8, 10, 11.5,<br>13, 16 & 18 mm<br>3.75 mm: 8, 10, 11.5,<br>13, 16 & 18 mm<br>4.0 mm: 7, 8, 10,<br>11.5, 13, 16 & 18 mm<br>4.3 mm: 7. 8, 10,<br>11.5, 13, 16 & 18 mm<br>5.0 mm: 7, 8, 10, 11.5,<br>13 & 16 mm | 3.4 mm: 8, 10, 12, 14,<br>16 and 18 mm<br>4.0 mm : 8, 10, 12, 14,<br>16 and 18 mm<br>4.6 mm : 6.5, 8, 10, 12<br>and 14 mm<br>5.2 mm : 6.5, 8, 10, 12<br>mm | Ø 4.5 mm : 6, 8, 10,<br>12, 14, 16 and 18 mm<br>Ø 5.5 mm : 6, 8, 10,<br>and 12mm<br>Ø 6.5 mm : 6, 8, 10,<br>and 12mm | Ø 3.4 mm : 16 and 18<br>mm<br>Ø 4.0 mm: 16 and 18<br>mm | Ø 3.4 mm : 8, 10, 12<br>and 14 mm<br>Ø 4.0 mm : 6, 8, 10, 12<br>and 14 mm<br>Ø 4.6 mm : 6, 8, 10, 12<br>and 14 mm<br>Ø 5.2 mm : 6, 8, 10, 12<br>and 14 mm | Ø 3.3mm : 8, 10, 12<br>and 14 mm<br>Ø 4.1mm : 6, 8, 10, 12<br>and 14 mm<br>Ø 4.8mm : 6, 8, 10, 12<br>and 14 mm |
| Thread Design | Tapered body | Apically Tapered, Dual<br>Helix | Tapered body | Tapered body | Tapered body | Tapered body | Tapered body |
| Surface finish | Sand blasted and acid<br>etched (BCP) | Sand blasted and acid<br>etched (Neoporos) | Sand blasted and acid<br>etched (BCP) | Hydrophilic SLActive® | Sand blasted and acid<br>etched (BCP) | Sand blasted and acid<br>etched (BCP) | SLA® - that is large-<br>grit sandblasted and<br>acid-etched |
| Material | Titanium-6Aluminum-<br>4Vanadium ELI (grade<br>23) | Commercially Pure<br>Titanium (Grade 4) | Titanium-6Aluminum-<br>4Vanadium ELI (grade<br>23) | Titanium-13 Zirconium<br>alloy (Roxolid®) | Titanium-6Aluminum-<br>4Vanadium ELI (grade<br>23) | Titanium-6Aluminum-<br>4Vanadium ELI (grade<br>23) | Titanium (Grade4)…