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U.S. Department of Health and Human Services

Product Classification

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Device cement, dental
Regulation Description Dental cement.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEMA
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 872.3275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Dental Cements - Premarket Notification; Final
Third Party Review
Accredited Persons

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