EKG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Condenser, Amalgam And Foil, Operative
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AUSTENAL CONDENSING INSTRUMENT (K865025) | Austenal Dental, Inc. | 1987-02-19 |
| ISOSTATIC CONDENSER (K843901) | Shofu Dental Corp. | 1984-12-03 |
| DENTAL INSTRUMENTS - PLUGGERS (K823322) | Miltex, Inc. | 1982-11-24 |
Track EKG automatically
Every clearance here is in the API, with alerts when new ones post.