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This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

The Intra-Lock International Transitional Implant System consists of root form Transitional Implants and restorative components which can be used for cement retained or and removable overdenture type restorative options. The implants are 1.8mm in width by 10, 15 and 8mm in length. The implants are sterile packaged and include a placement instrument.

The provided 510(k) summary for the Intra-Lock Transitional Implant System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a "Special 510(k): Abbreviated 510(k)" which typically relies on demonstrating conformity with recognized standards or guidance documents rather than presenting new clinical study data with specific acceptance criteria. The submission states it provides information to "demonstrate conformity with FDA's guidance document entitled Endosseous Implants 872-3640."

Therefore, I cannot populate the requested tables and answer the questions based on the provided text. The document concludes that the device is "safe and effective for its intended use" based on "indications for use, technological characteristics, and comparison to predicate devices," but it does not detail specific performance metrics, acceptance criteria, or a study that directly measures performance against those criteria.

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