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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 Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.6070
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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