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The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a computible formulation when in contact with Ti6A4V. If light retention is desired by the cinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements of an be used. The cast crown seated on this crown post may be single and free-sanding, part of fixed bridgework, or connected to a bar structure for overdenture retention.

Opti-Max Angled Crown Post for Externally-Hexed Implants

I am sorry, but the provided text is a 510(k) premarket notification approval letter from the FDA for a dental device (Opti-Max Angled Crown Post for Externally-Hexed Implants).

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This letter only states that the device is substantially equivalent to legally marketed predicate devices and can now be marketed.

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