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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeSBC
Regulation Number 872.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
DENTAL MONITORING SAS
  GRANTED 1

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