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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, 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.
Product CodeSHQ
Regulation Number 872.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
3SHAPE TRIOS A/S
  SUBSTANTIALLY EQUIVALENT 1

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