EBP · Reliner, Denture, Over The Counter
Dental · 21 CFR 872.3560 · Class 2
Overview
| Product Code | EBP |
|---|---|
| Device Name | Reliner, Denture, Over The Counter |
| Regulation | 21 CFR 872.3560 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
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. The special controls for this device are FDA's:
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.”
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121318 | PROSOFT | Perma Laboratories | Jun 6, 2012 | SESE |
| K101771 | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. | Sep 20, 2010 | SESE |
| K790589 | DENTURE-TIGHT | Den-Mat Corp. | Aug 10, 1979 | SESE |
Top Applicants
- Perma Laboratories — 1 clearance
- Majestic Drug Co., Inc. — 1 clearance
- Den-Mat Corp. — 1 clearance
