Dentures, Full

Device Code: 1412

Product Code(s): NSL

Definition: Foreign Dental Lab Manufactured Full Dentures Are Manufactured As Finished Products From Denture Resins.

Device Classification Information

Device Type ID1412
Device NameDentures, Full
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 CodeNSL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1412
DeviceDentures, Full
Product CodeNSL
TPLC Last Update: 2019-04-02 19:53:41

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.