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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental 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
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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