Strip, Polishing Agent

Device Code: 1172

Product Code(s): EHM

Device Classification Information

Device Type ID1172
Device NameStrip, Polishing Agent
Regulation DescriptionAbrasive Device And Accessories.
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 Number872.6010 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEHM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1172
DeviceStrip, Polishing Agent
Product CodeEHM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAbrasive Device And Accessories.
CFR Regulation Number872.6010 [🔎]
TPLC Last Update: 2019-04-02 19:49:21

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