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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00348783010053 | Premier File | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-27 |
| 07898506812134 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 07898506812127 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| ESAM12859001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12905001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12853001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12910001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12903001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 20860002195005 | Mx-Grafter | MAXILON LABORATORIES INC | 2020-08-03 |
| 10649111180651 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10649111180521 | Sklar® | SKLAR CORPORATION | 2018-11-26 |
| 10649111161100 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111181443 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111163739 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111163630 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111161841 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111161728 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111161346 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111161209 | Sklar® | SKLAR CORPORATION | 2018-09-10 |
| 10649111120657 | Sklar® | SKLAR CORPORATION | 2018-08-21 |
| 10649111120299 | Sklar® | SKLAR CORPORATION | 2018-08-21 |
| 10649111118241 | Sklar® | SKLAR CORPORATION | 2018-08-21 |
| 10649111117046 | Sklar® | SKLAR CORPORATION | 2018-08-21 |
| 10649111116339 | Sklar® | SKLAR CORPORATION | 2018-08-21 |
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| 10381780399247 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780399230 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780399223 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780208198 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780208174 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |