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U.S. Department of Health and Human Services

Product Classification
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Device dental image analyzer, in-office
Definition A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions.
Physical State May include hardware to capture the intraoral images and software to collect and analyze the images.
Technical Method Software that collects and analyzes intraoral images to be used as a diagnostic aid.
Target Area Oral Cavity/Mouth
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeSHQ
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 872.1770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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