(532 days)
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.
Specific indications for small diameter (03.3 mm implants):
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary lateral incisors or mandibular central and lateral incisors.
The implant system serves as anchorage for dental prosthetic restorations. Implants are placed in the bone of the upper or lower jaw. Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics, Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are titanium alloy 6Al 4V, feature internal and external hex implant to abutment connection options and are available with modified surfaces (TO2 layer) to promote improved osseointegration. Implant abutments are also titanium alloy 6A1 4V. Instruments and accessories necessary to place implants and abutments also form part of the system.
The provided text is a 510(k) Premarket Notification for the AVINENT Implant System. It describes the device, its intended use, a comparison with predicate devices, and concludes with a substantial equivalence determination. However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format typically associated with performance metrics like sensitivity, specificity, accuracy, or clinical endpoints.
Instead, this document focuses on demonstrating substantial equivalence to already legally marketed predicate devices based on:
- Material composition: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, consistent with predicate devices.
- Form/Features: Root-form, tapered, microthread, self-tapping with hexagonal internal/external connections, mirroring features in predicate devices.
- Dimensions: Diameters, lengths, and prosthetic connections are within the range of predicate devices.
- Surface Treatment: BAS (Biomimetic Advanced Surface) which is described as shot-blasted and anodized to form a titanium oxide layer, compared to TiUnite® and RBT surfaces in predicates. The key is the functionality of promoting osseointegration.
- Abutment Material: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, aligning with predicate devices.
- Implant/Abutment Connection: External Hex and Internal Hex, matching predicate devices.
- Abutment forms/Features: Straight and angled up to 30°, similar to predicate devices.
The "study" that supports this submission is explicitly stated as non-clinical bench testing:
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
"The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Bench testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including mechanical performance (fatigue) testing taking account of the level and duration of contact with the body, surface finish testing, packaging validation and sterilization process validation."
Therefore, the requested information elements related to clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not present in this document, as the device's clearance was based on substantial equivalence through non-clinical bench testing.
Here's a summary of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (AVINENT Implant System) |
|---|---|
| Material: Biocompatible, load-bearing material (e.g., Titanium Grade 5, Titanium CP Grade 4) | Titanium Grade 5 (TiAl6V4 ELI) for implants and abutments. PEEK also used for abutments. |
| Form/Features: Root-form, tapered, microthread, self-tapping, hexagonal internal/external connection (similar to predicate devices) | Root-form, tapered, microthread, self-tapping with hexagonal external connection (Coral Line) and root-form, microthread, self-tapping with hexagonal internal connection (Coral Line, Ocean Line) |
| Implant Diameters (Endosseous): Range typically 3.0 to 6.0 mm (as seen in predicates) | 3.3 to 5.0 mm |
| Implant Lengths: Range typically 7.0 to 18.0 mm (as seen in predicates) | 7.0 to 15.0 mm |
| Surface Treatment: Promotes osseointegration (e.g., TiUnite®, RBT) | BAS - Biomimetic Advanced Surface: shot-blasted and anodized to form titanium oxide layer on implant threads and collar. (Functionally equivalent to predicate surface treatments for promoting fixation). |
| Implant/Abutment Connection: Secure and stable (e.g., External Hex, Internal Hex, Internal Morse Taper) | External Hex and Internal Hex. |
| Abutment Forms/Features: Straight and angled options up to a certain degree (e.g., 15° to 30°) | Straight and angled up to 30°. |
| Mechanical Performance: Withstands foreseeable operating conditions, including fatigue testing (as per FDA guidance for dental implants) | Bench testing performed, specifically including mechanical performance (fatigue) testing. (No specific quantitative acceptance criteria or results are provided in the summary, just confirmation that it was done and showed "correct operation"). |
| Surface Finish, Packaging, Sterilization: Validated to ensure safety and function | Surface finish testing, packaging validation, and sterilization process validation were performed. (No specific acceptance criteria or results are provided in the summary, just confirmation that it was done and showed "correct operation"). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission is based on non-clinical bench testing and comparison to predicate devices, not a clinical test set.
- Data Provenance: Non-clinical bench testing. No country of origin for clinical data is applicable. Retrospective or prospective study design is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Human expert ground truth is not relevant for this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical "ground truth." The "ground truth" for demonstrating substantial equivalence rests on adherence to material standards, mechanical performance benchmarks, and functional similarity to predicate devices, verified through non-clinical testing.
8. The sample size for the training set:
- Not applicable. There is no AI component or training set involved.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.