EHJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Disk, Abrasive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6010
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2004: 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 |
|---|---|---|
| MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (K911111) | Vermont Diamond Instruments | 1991-11-19 |
| MIN-IDENTOFLEX (K873002) | Centrix, Inc. | 1987-08-17 |
| HOWMEDICA BRASS CENTER DISC (K790640) | E.C. Moore Co. | 1979-05-01 |
| IDENTOFLEX (K771658) | Cavitron Corp. | 1977-09-12 |
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Every clearance here is in the API, with alerts when new ones post.