EIK
5 FDA 510(k) clearances · Product code
80 daysmedian time to decision
195 days90th percentile
5clearances measured
FDA profile
- Official device name
- Carver, Wax, Dental
- 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 |
|---|---|---|
| NEOCALEX (K013993) | Stephen M Koral, Dmd | 2002-02-22 |
| PERIO CONTROL II (K972642) | Estrad B.V. | 1998-01-26 |
| PDS-2000 (K902653) | Intl. Equipment and Supply Corp. | 1990-09-13 |
| ROOT CANAL ORGANIZER (K860817) | Pacific Union Dental, Inc. | 1986-03-17 |
| 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (K851727) | Artiberia | 1985-07-02 |
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Every clearance here is in the API, with alerts when new ones post.