Restoration, Base Metal

Device Code: 1417

Product Code(s): NSQ

Definition: Foreign Dental Lab Manufactured Base Metal Restorations Are Crowns, Bridges, Inlays, And Onlays That Are Manufactured As Finished Products From Base Metals.

Device Classification Information

Device Type ID1417
Device NameRestoration, Base Metal
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 CodeNSQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1417
DeviceRestoration, Base Metal
Product CodeNSQ
TPLC Last Update: 2019-04-02 19:53:45

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