(311 days)
Anthogyr AXIOM® REG implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. The Axiom dental system is indicated for one-stage or two-stage surgery.
It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.
The AXIOM® REG Implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the expansion of prosthetic components and surgical instrumentation and also the implants of the AXIOM® REG.
Any abutment can be assembled on any AXIOM® REG implant thanks to its unique prosthetic connection, regardless of the implant diameter chosen.
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Implants
Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø3.4 mm, length: 16-18 mm
Ø 4.0 mm, length: 16-18 mm -
Conical abutments
Provide support for a permanent restoration, for multiple screw-retained prosthesis and screw-retained bar and brace
Material: Ti6Al4V
Dimensions: gingival height: 4.5 mm
angle: 18-30°
Rotational and non rotational abutments. -
Aesthetic titanium abutments
Provide support for a permanent restoration, single and multiple-unit cemented restoration.
Material: Ti6Al4V
Dimensions: Ø3.4 mm; gingival height: 2.5-4.5 mm; angle: 7-15°
Ø4.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23°
Ø5.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23°
Ø6.0 mm; gingival height: 1.5-4.5 mm; angle: 0-15°
Standard angulated titanium abutments
Provide support for a permanent restoration
Material: Ti6Al4V
Dimensions: Ø4.0 mm; gingival height: 1.5-3.5 mm; angle 15-23°
Ø5.0 mm; gingival height: 1.5-3.5 m; angle 15-23°
Temporary abutments
Provide support for a temporary restoration
Material: Ti6Al4V
Dimensions: Ø3.4 mm; height: 1.5-4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 1.5-4.5 mm
Healing screws and healing screws flat
Sealing of implant conical connection during bone healing. Prepare gingiva to the permanent restoration shape.
Material: Ti6Al4V
Dimensions: Ø3.4 mm; height: 4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 4.5 mm
Dimensions (flat version): Ø3.4 mm; height: 1.5-4.5 mm
Ø4.0 mm; height: 0.75-4.5 mm
Ø5.0 mm; height: 0.75-4.5 mm
Ø6.0 mm; height: 1.5-4.5 mm
Pacific system
Ensure passive fit between the conical abutment and the framework. Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments.
Materials: Ti6Al4V, PMMA
Temporary cap and protecting cap
Give the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration
Here's a breakdown of the acceptance criteria and study information for the AXIOM® REG device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device comparison) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Comparable mechanical properties to predicate devices. | A fatigue testing according to the standard NF EN ISO 14801 (2007) has been performed for added devices. Results demonstrate comparable mechanical properties to the predicate device. |
| Material | Similar material as legally marketed predicate devices. | "substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function." (Materials described as Ti6Al4V for implants and abutments, PMMA for Pacific system. These are standard in dental implants and implicitly comparable to predicates.) |
| Design | Similar design as legally marketed predicate devices. | "substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function." |
| Function | Similar function as legally marketed predicate devices. | "substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function." |
| Safety and Effectiveness | As safe and effective as predicate devices. | "Non clinical performance testing according to special control demonstrate that ANTHOGYR Endosseous dental implant system (AXIOM® REG) is as safe, effective, and performs as safely and effectively as its predicate devices." |
| Compliance | Conforms to Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. | "AXIOM® Endosseous dental implant systems (AXIOM® REG) conforms to Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff Document issued on May 12, 2004." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The text only mentions "fatigue testing" according to a standard, but does not detail the number of units tested.
- Data Provenance: Not explicitly stated as prospective or retrospective. The testing was "performed for added devices," suggesting it was conducted specifically for this submission (likely prospective in the context of this regulatory filing). The country of origin for the testing is not mentioned, but the submitter is based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The study described is a non-clinical, mechanical fatigue test, not a clinical study involving human expert assessment or ground truth establishment based on clinical observations.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As noted above, this was a mechanical test, not a study requiring adjudication of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
This information is not applicable and not provided. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a physical dental implant system and prefabricated components, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance testing was the established pass/fail criteria and performance characteristics defined by the NF EN ISO 14801 (2007) standard for fatigue testing of endosseous dental implants, against which the predicate devices presumably also complied. The objective was to demonstrate "comparable mechanical properties" to the predicate.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As above, there is no training set for this type of device.
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.