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To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodentic appliance in the mandible or maxilla.

ENDURE endosseous implant

This document is a 510(k) clearance letter for the ENDURE Endosseous Implant. It confirms that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include detailed information about clinical trials, performance metrics, ground truth, or expert qualifications in the way you've requested.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than extensive clinical studies with specified acceptance criteria as one might see for novel, high-risk devices or software as a medical device (SaMD).

Therefore, based solely on the provided text, I cannot fill in the requested table and information. Most of the points you've asked for are related to clinical studies and performance evaluation that are not typically included in a 510(k) clearance letter itself.

To answer your questions, one would need to access the full 510(k) submission (if publicly available or by contacting the manufacturer), which would contain the detailed test reports and justification for substantial equivalence.

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