EIF
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Accessories, Retractor, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2015: 8
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 |
|---|---|---|
| MOUTH PROPS (K940785) | Worldwide Dental, Inc. | 1994-10-05 |
| LEWIS SAFE SLEEVE (K873960) | Cheri Lewis, D.D.S. | 1987-12-04 |
| FOCUS FLUID (K830187) | Hematology Marketing Assoc. | 1983-03-01 |
| SULCARINGS (K830116) | North Pacific Dental, Inc. | 1983-02-18 |
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Every clearance here is in the API, with alerts when new ones post.