(90 days)
Algetral and Cavex Chromatic are dental impression materials based on alginate. They are used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. They are general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Cavex Chromatic has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.
Algetral and Cavex Chromatic are dental impression materials based on alginate.
This is a letter about the substantial equivalence of a medical device (dental impression materials) to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance, or a study proving device performance as it is a 510(k) clearance letter, not a detailed study report. Therefore, I cannot extract the requested information from 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).