§872.3660. Impression material.
21 C.F.R. § 872.3660
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.
Classification. Class II (Special Controls).
Notes, amendments, and revision history
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]