Plier, Orthodontic

Device Code: 1276

Product Code(s): JEX

Device Classification Information

Device Type ID1276
Device NamePlier, Orthodontic
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 CodeJEX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1276
DevicePlier, Orthodontic
Product CodeJEX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
Device Problems
Lack Of Maintenance Documentation Or Guidelines
1
Defective Component
1
Material Integrity Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 19:51:08

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