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 |
|---|---|---|---|
| G879OSTCVC270 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXS420 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXS370 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXS320 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXS270 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXS220 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXC420 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXC370 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXC320 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXC270 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVS420 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVS370 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVS320 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVS270 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVS220 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVC420 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVC370 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVC320 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCVC220 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879OSTCXC220 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| 04099797013214 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013184 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013153 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013139 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013108 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013078 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013047 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797013016 | SCREW-LINE Osteotome | ALTATEC GmbH | 2026-08-17 |
| 04099797012996 | SCREW-LINE Osteotomy set | ALTATEC GmbH | 2026-08-17 |
| 04099797012989 | SCREW-LINE Osteotomy set | ALTATEC GmbH | 2026-08-17 |