File, Bone, Surgical
The surgical bone file is a dental instrument used to smooth and reshape bone surfaces, typically following tooth extraction or during alveolar bone procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EMI, regulated under 21 CFR 872.4565 in the Dental specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EMI
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914035 | MINI-MILL | Mar 02, 1992 | Substantially Equivalent | Biomedical Composites, Ltd. |
| K912989 | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | Aug 16, 1991 | Substantially Equivalent | Wilde-USA, Inc. |
| K851716 | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K823676 | DISC NEEDLE SET #TX-8220 | Jan 09, 1983 | Substantially Equivalent | Today'S Machining & Design, Inc. |
FEI Numbers
This FDA classification entry is associated with 141 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 141 registration numbers. Click on an entry to view related FDA registrations.