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Device mercury
Regulation Description Dental mercury.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeELY
Submission Type 510(k)
Regulation Number 872.3700
Device Class 1
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
Accredited Persons

 
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