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 |
|---|---|---|---|
| ESAM13290021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13333011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13311011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13290011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13290031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13290041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13291011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13291021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13291031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13291041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13310061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 10649111012617 | Sklar® | SKLAR CORPORATION | 2018-08-24 |
| 10649111013263 | Sklar® | SKLAR CORPORATION | 2018-08-24 |
| 10649111013911 | Sklar® | SKLAR CORPORATION | 2018-08-24 |
| 10649111014109 | Sklar® | SKLAR CORPORATION | 2018-07-31 |