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U.S. Department of Health and Human Services

Product Classification

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Device crown and bridge, temporary, resin
Regulation Description Temporary crown and bridge resin.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEBG
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
Recognized Consensus Standards
Third Party Review
Accredited Persons

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