Curette, Surgical, Dental
The dental surgical curette is a spoon-shaped instrument used to scrape and clean the walls of a tooth socket or other bone cavities during dental and oral surgical procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EMK, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EMK
- 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 |
|---|---|---|---|---|
| K851718 | 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES | Jul 02, 1985 | Substantially Equivalent | Artiberia |
FEI Numbers
This FDA classification entry is associated with 123 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 123 registration numbers. Click on an entry to view related FDA registrations.