(238 days)
[A] Temporary inlay and onlay treatments of the cavity [B] Sealing of openings for implant screws [C] Relining material for temporary crowns and bridges [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions [E] Covering of the gingival margin [F] Fixing of resin matrix during filling placement [G] Temporary filling of cavities
Not Found
The provided document is an FDA 510(k) clearance letter for a dental device called "Clip Flow". It addresses the regulatory aspects of the device and its indications for use, but it does not contain any information regarding acceptance criteria, study details, or performance data of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on this document. The document primarily confirms the substantial equivalence of the device to a predicate device for its stated indications for use.
To answer your questions, I would need access to the actual 510(k) submission or related performance studies, which are not included 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.