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U.S. Department of Health and Human Services

Product Classification
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Device device, dental sonography, for diagnosis of tmj / mpd disorders
Regulation Description Dental sonography device.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNFP
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.2050
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 Not Third Party Eligible
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