Code of Federal Regulations · Section
§ 872.3760 — Denture Relining, Repairing, Or Rebasing Resin
21 C.F.R. § 872.3760
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351