Eraser, Dental Stain

Device Code: 1316

Product Code(s): MAU

Device Classification Information

Device Type ID1316
Device NameEraser, Dental Stain
Regulation DescriptionManual Toothbrush.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.6855 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeMAU
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1316
DeviceEraser, Dental Stain
Product CodeMAU
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Toothbrush.
CFR Regulation Number872.6855 [🔎]
TPLC Last Update: 2019-04-02 19:51:53

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