Dentures, Partial

Device Code: 1411

Product Code(s): NSK

Definition: Foreign Dental Lab Manufactured Partial Dentures Are Manufactured As Finished Products From Denture Resins And Other Supporting Materials.

Device Classification Information

Device Type ID1411
Device NameDentures, Partial
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 CodeNSK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1411
DeviceDentures, Partial
Product CodeNSK
TPLC Last Update: 2019-04-02 19:53:40

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