Product code EML
- Device name
- Chisel, Bone, 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198506092060 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |
| 00198506092077 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |
| 00198506092084 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |
| 00198506092091 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |
| 00198506092053 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |
| 00198506092107 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-17 |
| 00198506092114 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-17 |
| 00198506092121 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-17 |
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