DENTURE-TIGHT
Device Facts
| Record ID | K790589 |
|---|---|
| Device Name | DENTURE-TIGHT |
| Applicant | Den-Mat Corp. |
| Product Code | EBP · Dental |
| Decision Date | Aug 10, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.
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. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
