21 CFR 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.