CONCEPT II
Device Facts
| Record ID | K790339 |
|---|---|
| Device Name | CONCEPT II |
| Applicant | Richardson Merrel, Inc. |
| Product Code | EBE · Dental |
| Decision Date | Jul 17, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3300 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
