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U.S. Department of Health and Human Services

Product Classification

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Device activator, ultraviolet, for polymerization
Regulation Description Ultraviolet activator for polymerization.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEBZ
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 872.6070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Dental Curing Lights - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107711.htm] 
Third Party Review
Accredited Persons

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