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For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

This 510(k) summary does not describe an AI/ML medical device, but rather a dental implant system (Spline X Endosseous Dental Implant System). Therefore, the specific information requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is largely not applicable or not provided in the context of this traditional medical device submission.

The document primarily focuses on establishing substantial equivalence to a predicate device (Calcitek's existing Spline Dental Implant System) by demonstrating similar intended use, description, and technological characteristics (design and materials). The "comparison analysis" section reinforces this by highlighting similarities in design, prostheses, and coating material.

Without further information from a different document describing an AI/ML device, I cannot fulfill the request as specified.

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