Implant, Transmandibular

Device Code: 1318

Product Code(s): MDL

Device Classification Information

Device Type ID1318
Device NameImplant, Transmandibular
Regulation DescriptionBone Plate.
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)
CFR Regulation Number872.4760 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMDL
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1318
DeviceImplant, Transmandibular
Product CodeMDL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBone Plate.
CFR Regulation Number872.4760 [🔎]
TPLC Last Update: 2019-04-02 19:51:55

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