(52 days)
Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.
The provided text is a 510(k) Summary of Safety and Effectiveness for a dental impression material named "Stand Out." It contains information about the device's name, common name, classification, predicate devices, device description, and intended use. However, it does not include any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical studies (such as MRMC or standalone studies).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document focuses on regulatory submission for substantial equivalence rather than reporting detailed study results or performance metrics.
§ 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).