File, Periodontic
The periodontic file is a dental instrument used to crush tenacious subgingival calculus deposits and smooth root surfaces during periodontal debridement procedures. It is classified as FDA Class 1, the lowest regulatory risk category, subject only to general controls. The product code is EMR, 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
- EMR
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830109 | CIMPAT | Mar 01, 1983 | Substantially Equivalent | North Pacific Dental, Inc. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.