JEW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tip, Rubber, Oral Hygiene
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6650
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1994: 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 |
|---|---|---|
| RABINOWITZ GUM MASSAGER (K862635) | Arnell, Inc. | 1986-09-25 |
| CHEW-DENT (K843406) | Senair-Mot | 1984-12-11 |
| ASSAY REAGENTS, LSA 290 (K790588) | Kallestad Laboratories, Inc. | 1979-05-15 |
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Every clearance here is in the API, with alerts when new ones post.