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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 Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons