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U.S. Department of Health and Human Services

Product Classification

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Device caries detector, laser light, transmission
Regulation Description Laser fluorescence caries detection device.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNTK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.1745
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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