File, Margin Finishing, Operative
The Operative Margin Finishing File is a hand instrument with a serrated or textured working surface used to smooth, finish, and refine the cavity margins and internal walls of tooth preparations prior to placing a restoration. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKA, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKA
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.