Band, Preformed, Orthodontic

Device Code: 1135

Product Code(s): ECM

Device Classification Information

Device Type ID1135
Device NameBand, Preformed, Orthodontic
Regulation DescriptionOrthodontic Appliance 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 Number872.5410 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeECM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1135
DeviceBand, Preformed, Orthodontic
Product CodeECM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthodontic Appliance And Accessories.
CFR Regulation Number872.5410 [🔎]
TPLC Last Update: 2019-04-02 19:48:51

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