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U.S. Department of Health and Human Services

Product Classification

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Device dental amalgam
Regulation Description Dental amalgam, mercury, and amalgam alloy.
Definition Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth.
Physical State Powder and liquid metals encapsulated and separated by a septum. Forms a solid upon mixing.
Technical Method Heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material
Target Area Direct filling of teeth.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeOIV
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
Guidance Document
  • Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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