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U.S. Department of Health and Human Services

Product Classification
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Device dental image analyzer
Definition A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress.
Physical State May include hardware to capture the optical camera-based intraoral images and software to collect and analyze the images.
Technical Method Software that collects and analyzes camera-based intraoral images to be used as a diagnostic aid and to monitor treatment progress.
Target Area Oral Cavity/Mouth
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeSBC
Premarket Review Division of Dental and ENT Devices (DHT1B)
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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