Cleaner, Denture, Mechanical

Device Code: 1272

Product Code(s): JER

Device Classification Information

Device Type ID1272
Device NameCleaner, Denture, Mechanical
Regulation DescriptionMechanical Denture Cleaner.
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 Number872.3530 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJER
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1272
DeviceCleaner, Denture, Mechanical
Product CodeJER
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMechanical Denture Cleaner.
CFR Regulation Number872.3530 [🔎]
TPLC Last Update: 2019-04-02 19:51:03

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