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U.S. Department of Health and Human Services

Product Classification

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Device crown and bridge, long-term temporary, resin
Regulation Description Temporary crown and bridge resin.
Definition For the fabrication of long-term temporary crowns and bridges
Physical State Polymeric, may include ceramic filler
Technical Method Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication
Target Area oral cavity
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePOW
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible