21 CFR 872.3300 — Coating, Denture Hydrophilic, Resin
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3300
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBE | Coating, Denture Hydrophilic, Resin | 2 | 3 |
Special Controls
EBE — Coating, Denture Hydrophilic, Resin
*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.
eCFR
