(112 days)
Suitable for routine use in conservative Class III and V restorations, for small non stress-bearing Class IV restorations, for minimal Class I restorations and for Gingival Wall of Class II restorations.
Wave is also suitable for:-
Veneers: Sealing teeth after air abrasion: Paediatric restorations; Minimal Class I and II restorations; Small restorations for enamel defects; Small occlusal build ups; Incisal abrasions: Minor core build ups: Splinting teeth; Porcelain repairs: Luting cement; Pit & fissure sealant.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the "WAVE" device does not contain the detailed information required to answer your request about acceptance criteria, study design, and performance metrics.
This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device already on the market. It describes the regulatory classification and general controls, as well as the intended indications for use. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, training sets, or data provenance.
- Information on expert qualifications, ground truth establishment, or adjudication methods.
- Results of comparative effectiveness studies (MRMC) or standalone algorithm performance.
To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the technical data and clinical/bench test reports that the FDA reviewed to make its determination. These submission documents are generally much more extensive than the clearance letter.
§ 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.