EBP
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reliner, Denture, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3560
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1996: 1 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PROSOFT (K121318) | Perma Laboratories | 2012-06-06 |
| RELINE-IT MODEL RELINE-IT (K101771) | Majestic Drug Co., Inc. | 2010-09-20 |
| DENTURE-TIGHT (K790589) | Den-Mat Corp. | 1979-08-10 |
Track EBP automatically
Every clearance here is in the API, with alerts when new ones post.