(44 days)
Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patients teeth, inlays and dentures. It is also intended to provide models of outletted in as dental inlays and dentures.
Not Found
This document is a 510(k) premarket notification from the FDA and does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.
The document states that the FDA has reviewed the 510(k) submission for the "Hydrogum 5" dental impression material and determined it is substantially equivalent to legally marketed predicate devices. This means the device is considered as safe and effective as other similar devices already on the market, but it does not provide details of specific performance criteria or a study proving it meets them.
Therefore, I cannot provide the requested information based on the provided text.
§ 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).