(50 days)
Registrado X-tra is intended for reproducing the structure of a patient's teeth and gums, to provide models in bite registration, fixing of facebow registration, and as a locator material for an intraoral pin tracing template.
Not Found
The document is a 510(k) clearance letter from the FDA for a dental impression material named "Registrado X-tra". It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The letter is primarily a regulatory approval document confirming substantial equivalence and outlining ongoing compliance requirements for the manufacturer. It does not include the technical study details typically found in a device's submission dossier.
Therefore, I cannot provide the requested table and 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).