Chisel, Bone, Surgical
The surgical bone chisel is a dental instrument used to cut or split bone during oral and maxillofacial surgical procedures. It is classified as FDA Class 1, indicating minimal risk and requiring only general controls, with no premarket submission needed. The product code is EML, regulated under 21 CFR 872.4565 in the Dental specialty. No special flags apply to this device.
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Basic Information
- Product Code
- EML
- 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 157 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 157 registration numbers. Click on an entry to view related FDA registrations.