(28 days)
Intended Use:
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
Not Found
I am sorry, but the provided text from the FDA 510(k) K042819 letter for "TETRIC EVOCERAM" only constitutes a clearance letter for a dental resin material. It does not contain any information about a study with acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement as typically related to the evaluation of AI/ML-driven medical devices.
The document is a standard FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the dental resin.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and performance metrics because it is not present in the provided text.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.