Product code EIS
- Device name
- Remover, Crown
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992649 | ATD AUTOMATIC BRIDGE REMOVER | J. Morita USA, Inc. | 1999-10-29 |
| K951299 | EASY PNEUMATIC CROWN AND BRIDGE REMOVER | Dentco, Inc. | 1995-08-29 |
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | Pacific Union Dental, Inc. | 1986-09-22 |
| K854795 | HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER | Fran Hazelton Co. | 1986-03-04 |
| K842026 | H-TYPE BRIDGE REMOVER | Higa Manufacturing , Ltd. | 1984-07-11 |
| K833287 | SATIN CAST ECONOCAST | Genesis Industries, Inc. | 1984-01-03 |
| K833290 | C & B 40 PENTRO C & B40 | Genesis Industries, Inc. | 1984-01-03 |
| K833278 | C & B 45 | Genesis Industries, Inc. | 1983-12-29 |
| K833289 | C & B 61 PENTRON C & B61 | Genesis Industries, Inc. | 1983-12-29 |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | 1983-12-29 |
| K833280 | SUPRA AP CHOICE 83 | Genesis Industries, Inc. | 1983-12-26 |
| K833285 | RX IV PENTRON IV | Genesis Industries, Inc. | 1983-12-22 |
| K833288 | C & B57 PENTRON C & B57 | Genesis Industries, Inc. | 1983-12-20 |
| K833286 | RX SEG ECONOPLUS | Genesis Industries, Inc. | 1983-11-28 |
| K833284 | RX 41 PENTRON 41 | Genesis Industries, Inc. | 1983-11-28 |
| K833283 | RX ORY PENTRON C & B | Genesis Industries, Inc. | 1983-11-28 |
| K833282 | RX NYSP PENTRON 60 | Genesis Industries, Inc. | 1983-11-28 |
| K833281 | RX D PENTRON | Genesis Industries, Inc. | 1983-11-28 |
| K833279 | NATURELLE-LITE | Genesis Industries, Inc. | 1983-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G149TBSB4270 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| 08800075627353 | OSUNG MND | OSUNG MND Co., Ltd. | 2025-11-03 |
| 08800075627346 | OSUNG MND | OSUNG MND Co., Ltd. | 2025-11-03 |
| ESAM5304001 | STOMA® | Storz am Mark GmbH | 2023-06-05 |
| 10889950015985 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| 10889950013516 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| 10889950007171 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| 10889950007126 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| 10889950007010 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| 10889950007003 | HU-FRIEDY | HU-FRIEDY MFG. CO., LLC | 2020-11-12 |
| ESAM5315021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5302001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5305001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5325001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5315011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5315031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5315101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5316001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5318051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5318061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5318081 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5312001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
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