Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart D - Prosthetic Devices / § 872.3300 Hydrophilic resin coating for dentures.
§ 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.