Code of Federal Regulations · Section
§ 872.3690 — Tooth Shade Resin Material
21 C.F.R. § 872.3690
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351