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U.S. Department of Health and Human Services

Product Classification

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Device laser activator for polymerization
Definition Intended to polymerize dental restorative resins
Physical State Handheld device including a light guide, a rechargeable battery, a charging station and barrier sleeve and eye protection accessories
Technical Method Laser energy, in the form of coherent light, is directed by means of optical focusing lenses to cure photoactivated dental restorative resins
Target Area Used intraorally on resin restorative surfaces
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQNF
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible