Instrument, Cutting, Operative

Device Code: 1216

Product Code(s): EKD

Device Classification Information

Device Type ID1216
Device NameInstrument, Cutting, Operative
Regulation DescriptionDental Hand Instrument.
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 Number872.4565 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEKD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1216
DeviceInstrument, Cutting, Operative
Product CodeEKD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
Device Problems
Fitting Problem
1
Break
1
Fracture
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 19:50:08

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