Product code EMI
- Device name
- File, 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914035 | MINI-MILL | Biomedical Composites, Ltd. | 1992-03-02 |
| K912989 | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | Wilde-USA, Inc. | 1991-08-16 |
| K851716 | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | Artiberia | 1985-06-11 |
| K823676 | DISC NEEDLE SET #TX-8220 | Today'S Machining & Design, Inc. | 1983-01-09 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G879106216H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879106217H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879106218H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| G879106214H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-08 |
| 07898506812127 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 07898506812134 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| ESAM12853001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12859001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12903001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12905001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12910001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
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| 10649111163739 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
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| 10381780208174 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |