(a)Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
(b)Classification. Class II (Special Controls).
[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]
Title 21 published on 2014-04-01
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