(243 days)
Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "ClearMet" device, which is a denture relining, repairing, or rebasing resin.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.
The letter primarily confirms that the FDA has reviewed the 510(k) submission for ClearMet and determined it to be substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.
Therefore, I cannot provide the requested information based on this document.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.