Crown & Bridge Material, Resin Based

Device Code: 1424

Product Code(s): PKJ

Definition: Used For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications.

Device Classification Information

Device Type ID1424
Device NameCrown & Bridge Material, Resin Based
Physical StateUsed For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications
Technical MethodUsed For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications
Target AreaTooth
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 TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodePKJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1424
DeviceCrown & Bridge Material, Resin Based
Product CodePKJ
TPLC Last Update: 2019-04-02 19:53:51

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