Clasp, Preformed

Device Code: 1174

Product Code(s): EHP

Device Classification Information

Device Type ID1174
Device NameClasp, Preformed
Regulation DescriptionPreformed Clasp.
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 Number872.3285 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEHP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1174
DeviceClasp, Preformed
Product CodeEHP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPreformed Clasp.
CFR Regulation Number872.3285 [🔎]
TPLC Last Update: 2019-04-02 19:49:23

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