(60 days)
The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.
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The provided text is a 510(k) premarket notification letter from the FDA to Sirona Dental Systems, GmbH, regarding the CEREC® 3 Ceramic Dental Restoration System. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, or comparative effectiveness studies. It is a regulatory approval letter that confirms the device can be marketed.
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.
§ 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).