(24 days)
StatusBlue is indicated for use as a dental impression material in the following applications:
- Situation impressions of any kind;
- Impressions for the preparation of provisionals;
- Impressions for orthodontic models;
- Impressions of the opposing jaw;
- Impressions for the manufacture of model cast dentures
The StatusBlue dental impression material is a dimensionally stable polyvinyl siloxane material designed as an alternative to alginate impression materials. It will be supplied in prefilled, ready-to-use MixStar cartridges. StatusBlue is intended for use in commercially available impression trays.
The provided text states: "Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.
§ 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).