Wheel, Polishing Agent
The Polishing Agent Wheel is a circular, rubber- or silicone-based rotary instrument impregnated with abrasive particles, mounted in a dental handpiece to polish and smooth the surfaces of restorations, prosthetic components, and tooth enamel. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJQ, regulated under 21 CFR 872.6010 in the Dental (DE) specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- EJQ
- Device Class
- FDA class 1
- Regulation Number
- 872.6010
- 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 |
|---|---|---|---|---|
| K781777 | ABRASIVE WHEELS | Dec 20, 1978 | Substantially Equivalent | Dentsply Intl. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.