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3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

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I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain information about acceptance criteria or the study that proves a device meets those criteria, specifically concerning an AI/ML medical device.

The document is a clearance letter for a dental device called "3.0 Dynamic TiBase," which is a physical endosseous dental implant abutment. The content discusses:

• The FDA's review and determination of substantial equivalence to legally marketed predicate devices.
• Regulatory classifications, general controls, and additional controls (if applicable).
• Requirements for registration, listing, labeling, medical device reporting, and good manufacturing practices.
• Contact information for the FDA's Division of Industry and Consumer Education.
• The "Indications for Use" for the 3.0 Dynamic TiBase, including compatibility with specific implant systems (DIO® and OSSTEM®), dimensions, retention type, screw type, angulation, and abutment connection.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance, especially for an AI/ML device, as this document is not related to such a product or study.

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