Eraser, Dental Stain
The dental stain eraser is a device used to mechanically remove surface stains from tooth enamel, improving dental aesthetics as part of routine dental hygiene or professional cleaning procedures. It is classified as FDA Class I within the Dental specialty under 21 CFR 872.6855, subject only to general controls. The product code is MAU and the device is GMP-exempt, meaning it is not subject to full quality system regulation requirements. It is not an implant and does not sustain life.
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Basic Information
- Product Code
- MAU
- Device Class
- FDA class 1
- Regulation Number
- 872.6855
- 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 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.