(59 days)
Mega Bite is designed for making accurate occlusal records.
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This document is a 510(k) clearance letter from the FDA for a dental impression material called "Mega Bite Registration." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The letter is primarily a regulatory communication stating that the device can be marketed. It does not detail the technical performance or the studies conducted to establish substantial equivalence.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).