21 CFR 872.3600 - Partially fabricated denture kit.
(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.
(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.