(80 days)
Fit Test C&B is intended for the following applications: Control of precise fit, marginal tightness and marginal gap of - full or partial crowns - bridges - inlays/onlays - cast post cores/post crowns - metal bases - implant-supported crowns and bridges - attachments and other secondary parts of dentures
Not Found
I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Fit Test C&B." It primarily discusses regulatory classification and general controls.
The document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot extract the information you requested about the study that proves the device meets acceptance criteria.
§ 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).