Search Results

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0

Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.

The Titanium Abutment Blanks are used for fabrication of all-titanium patient-specific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.

The provided text describes the submission of Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System for FDA 510(k) clearance, asserting substantial equivalence to predicate devices. The study conducted is primarily non-clinical performance testing.

Here's the breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format alongside specific reported device performance values. Instead, it states that "The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties." and that "Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007." This implies that the acceptance criteria are met if the device's performance is comparable to, or within the established range of, the predicate devices under the specified ISO standard for dental implants.

The reported device performance is that it met the requirements of ISO 14801:2007 through Reliability Calculation, Fatigue Testing, and Static Load Failure Testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing).

The data provenance is retrospective, as it relies on established standards and comparative testing against predicate devices. The document does not mention the country of origin of the data, but the testing was conducted to meet FDA guidance and ISO standards.

3. Number of Experts and their Qualifications for Ground Truth

This question is not applicable to this submission. The ground truth for this type of device (dental abutments) is established through objective, standardized mechanical and material testing as per ISO and FDA guidance, rather than expert consensus on interpretive data (e.g., medical images).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic studies. For mechanical performance testing, the results are objectively measured against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The device in question is a dental abutment, and its effectiveness is determined by mechanical and material properties, not human interpretation of cases.

6. Standalone Performance Study (Algorithm Only)

No. A standalone algorithm performance study was not done. This device is a physical medical device (dental abutment), not an AI algorithm. Its performance is assessed through laboratory testing, not algorithmic output without human involvement.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and regulatory guidance. Specifically:

• ISO 14801:2007: Standard for fatigue testing of endosseous dental implants.
• FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
• Material Standards: ASTM standard F-136 for Ti-6Al-4V ELI.
• Biocompatibility Testing: Applicable prior biocompatibility testing for reference devices K121406 and K143353 (Sensitization, Cytotoxicity, and Systemic Toxicity).

These standards define the acceptable mechanical properties, material composition, and biological safety for such devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for a physical dental abutment.

Ask a specific question about this device