(77 days)
HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for two dental devices, "Hi-Wave" and "Pour-Plus" denture base acrylics. It does not contain any information regarding acceptance criteria, device performance, sample sizes used in studies, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study proving it meets those criteria. The document only states that the devices are substantially equivalent to legally marketed predicate devices.
§ 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.