Pliers, Operative

Device Code: 1211

Product Code(s): EJY

Device Classification Information

Device Type ID1211
Device NamePliers, 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 CodeEJY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1211
DevicePliers, Operative
Product CodeEJY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
TPLC Last Update: 2019-04-02 19:50:04

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