EIS
19 FDA 510(k) clearances · Product code
84 daysmedian time to decision
103 days90th percentile
19clearances measured
FDA profile
- Official device name
- Remover, Crown
- 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 |
|---|---|---|
| ATD AUTOMATIC BRIDGE REMOVER (K992649) | J. Morita USA, Inc. | 1999-10-29 |
| EASY PNEUMATIC CROWN AND BRIDGE REMOVER (K951299) | Dentco, Inc. | 1995-08-29 |
| STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (K863500) | Pacific Union Dental, Inc. | 1986-09-22 |
| HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (K854795) | Fran Hazelton Co. | 1986-03-04 |
| H-TYPE BRIDGE REMOVER (K842026) | Higa Manufacturing , Ltd. | 1984-07-11 |
| SATIN CAST ECONOCAST (K833287) | Genesis Industries, Inc. | 1984-01-03 |
| C & B 40 PENTRO C & B40 (K833290) | Genesis Industries, Inc. | 1984-01-03 |
| C & B 45 (K833278) | Genesis Industries, Inc. | 1983-12-29 |
| GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (K833736) | Jeneric Ind. | 1983-12-29 |
| C & B 61 PENTRON C & B61 (K833289) | Genesis Industries, Inc. | 1983-12-29 |
| SUPRA AP CHOICE 83 (K833280) | Genesis Industries, Inc. | 1983-12-26 |
| RX IV PENTRON IV (K833285) | Genesis Industries, Inc. | 1983-12-22 |
| C & B57 PENTRON C & B57 (K833288) | Genesis Industries, Inc. | 1983-12-20 |
| RX SEG ECONOPLUS (K833286) | Genesis Industries, Inc. | 1983-11-28 |
| RX 41 PENTRON 41 (K833284) | Genesis Industries, Inc. | 1983-11-28 |
| RX D PENTRON (K833281) | Genesis Industries, Inc. | 1983-11-28 |
| RX ORY PENTRON C & B (K833283) | Genesis Industries, Inc. | 1983-11-28 |
| NATURELLE-LITE (K833279) | Genesis Industries, Inc. | 1983-11-28 |
| RX NYSP PENTRON 60 (K833282) | Genesis Industries, Inc. | 1983-11-28 |
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Every clearance here is in the API, with alerts when new ones post.