EMI — File, Bone, Surgical Class I
FDA product code EMI covers "File, Bone, Surgical", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EMI
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914035 | biomedical composites | MINI-MILL | March 2, 1992 |
| K912989 | wilde-usa | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | August 16, 1991 |
| K851716 | artiberia | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | June 11, 1985 |
| K823676 | today machining and design | DISC NEEDLE SET #TX-8220 | January 9, 1983 |