Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We have made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom
right of each page!
|
e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 872 → Subpart D → §872.3300 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§872.3300 Hydrophilic resin coating for dentures.
(a) Identification. A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.
(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.
[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]