Denture, Cosmetic Only

Device Code: 1419

Product Code(s): NXJ

Definition: Intended To Improve An Individual's Appearance Only. Not Intended To Assist In Chewing Food.

Device Classification Information

Device Type ID1419
Device NameDenture, Cosmetic Only
Physical StateDenture Rebasing Resin, Methylmethacrylate
Technical MethodFunctions Independently
Target AreaOral Cavity
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 CodeNXJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1419
DeviceDenture, Cosmetic Only
Product CodeNXJ
TPLC Last Update: 2019-04-02 19:53:47

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