Product code EMM
- Device name
- Chisel, Osteotome, Surgical
- 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 |
|---|---|---|---|
| K963897 | STERI-OSS SINUS AUGMENTATION KIT | Steri-Oss, Inc. | 1996-11-06 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | New England Surgical Instrument Corp. | 1987-02-12 |
| K851714 | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS | Artiberia | 1985-06-11 |
| K760959 | SURGICAL CHISEL | American Safety Equipment Corp. | 1976-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995268206 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00724995268213 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00724995268220 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00724995268190 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00190776432836 | Millennium | Avalign Technologies, Inc. | 2026-09-29 |
| 07392532219337 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-11 |
| 07392532219290 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-11 |
| 07392532219320 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-10 |
| 07392532219313 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-10 |
| 07392532219306 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-10 |
| 07392532219283 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-11-10 |
| 07392532219344 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219276 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219269 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219252 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219245 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219238 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219221 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219214 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219207 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219191 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219184 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219177 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219160 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219153 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 07392532219146 | ANKYLOS® | Dentsply Implants Manufacturing GmbH | 2022-07-14 |
| 10885403152771 | Snowden-Pencer | STERIS CORPORATION | 2018-07-13 |
| 10885403152764 | Snowden-Pencer | STERIS CORPORATION | 2018-07-13 |
| 10885403152757 | Snowden-Pencer | STERIS CORPORATION | 2018-07-13 |
| 10885403152740 | Snowden-Pencer | STERIS CORPORATION | 2018-07-13 |