(139 days)
Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth. The document is a 510(k) clearance letter from the FDA for a dental device called "Activator Paste," indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but no performance study details are included.
§ 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).