Instrument, Cutting, Operative
The Operative Cutting Instrument encompasses a range of dental hand instruments including chisels, hatchets, and hoes used to cut, cleave, and refine tooth structure during cavity preparation, ensuring proper form and resistance for restorations. These are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKD, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKD
- 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 72 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 72 registration numbers. Click on an entry to view related FDA registrations.