(240 days)
A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material that is used for all crown und bridge, edentulous, orthodonic and impliant impression techniques.
A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material
This document is concerned with the 510(k) premarket notification for a dental impression material, specifically "A Silicone Dentistry-Elastic Impression Material" with the trade name PERFIT (K133071). It is not a medical device that relies on AI or algorithms, and therefore, the requested information (acceptance criteria, study details relating to AI performance, ground truth, expert consensus, etc.) is not applicable to this submission.
The FDA 510(k) clearance process for devices like impression materials typically involves demonstrating substantial equivalence to a legally marketed predicate device through performance testing (e.g., physical and chemical properties as per ISO standards) and biocompatibility testing, rather than clinical studies with human readers or AI performance metrics.
Therefore, I cannot provide the requested table and details because they are not part of the information typically submitted or reviewed for a conventional dental impression material like the one described.
§ 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).