Product Code: MAU FDA class 1 21 CFR 872.6855

Eraser, Dental Stain

Dental

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.

510(k)s
2
FEI Numbers
63
Registration Numbers
63
Unique Applicants
2
Years Active
10

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K000140 CLINI-DENT
K891338 SMYLON (DENTAL STAIN ERASER)

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.