(33 days)
Zhermack TROPICALGIN is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
Zhermack TROPICALGIN is a dental impression material.
This document is a 510(k) premarket notification decision letter for a dental impression material named "Tropicalgin". It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is regulatory correspondence and does not describe a performance study or its results.
§ 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).