(43 days)
The device is an additional-cure viny| polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Star VPS, First Half, First Quarter." This document is a regulatory approval letter, not a study report or clinical trial result.
Therefore, the requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set) cannot be extracted from this document, as it does not contain such information.
The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. The indications for use are provided: "The device is an additional-cure vinyl polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques."
§ 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).