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U.S. Department of Health and Human Services

Product Classification

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Device mercury
Regulation Description Dental amalgam, mercury, and amalgam alloy.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeELY
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 872.3070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff
Third Party Review
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