EIG
8 FDA 510(k) clearances · Product code
57 daysmedian time to decision
95 days90th percentile
8clearances measured
FDA profile
- Official device name
- Retractor, All Types
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1997: 1 · 2005: 2 · 2012: 7
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 |
|---|---|---|
| OPALDAM (K971284) | Ultradent Products, Inc. | 1997-06-03 |
| FIBRELIGHT ILLUMINATING ORAL RETRACTORS (K854711) | Downs Surgical , Ltd. | 1986-02-25 |
| ZOLLER BURNED LIP CONFORMER (K832366) | Universal Prosthetics, Inc. | 1983-09-26 |
| BEACH GINGIVAL RETRACTION INSTR. TYPE B (K821784) | Pacific Dental Corp. | 1982-07-06 |
| GINGITRACT (K771973) | Den-Mat Corp. | 1977-11-07 |
| LIP & CHEEK RETRACTOR (K771399) | L.D. Caulk Co. | 1977-08-26 |
| RACESTYPTINE RINGS (K761024) | Septodont, Inc. | 1976-11-19 |
| RACESTYPTINE CORD (K760657) | Septodont, Inc. | 1976-09-27 |
Track EIG automatically
Every clearance here is in the API, with alerts when new ones post.