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IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process.

The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace.

All components are to be used as labeled. Components are not intended to be bent, cast or altered by the clinician.

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The provided text is a 510(k) clearance letter from the FDA for a dental implant system. This document is a regulatory approval and does not contain any information regarding acceptance criteria, study details, or performance metrics of the device as it relates to clinical outcomes or algorithm performance.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided input. This type of information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided text.

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