(84 days)
emulate Fast Set and emulate Regular Set are dental impression materials based on alginate. They are suitable for taking impressions of the oral cavity with the purpose of constructing a gypsum model that equals the situation in the mouth. They are used for making study models, first impressions for general purpose impressions, situation models, orthodontic impressions etc.
emulate Fast Set & emulate Regular Set Alginate Impression Materials
The provided text is a 510(k) premarket notification letter from the FDA regarding an alginate impression material. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
Therefore, I cannot provide the requested information. The document solely focuses on the FDA's determination of substantial equivalence for the specified dental impression material.
§ 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).