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Code of Federal Regulations Title 21. Food and Drugs § 21.872.3600 Partially fabricated denture kit

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in construction of a denture. A denture base is constructed using the patient's mouth as a mold, by partially polymerizing the resin denture base materials while the materials are in contact with the oral tissues. After the denture base is constructed, the connected preformed teeth are chemically bonded to the base.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I:  Evaluation and Testing,’ ” and

(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.872.3600 Partially fabricated denture kit - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-872-3600/

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