(58 days)
The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.
The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System.
The provided text is a 510(k) clearance letter from the FDA for the Cerac 2 Crown Software. It states that the device is substantially equivalent to a predicate device but does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.
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. The document is solely a regulatory clearance and does not delve into the technical validation of the device.
§ 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).