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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device x-ray, tomography, computed, dental
Regulation Description Computed tomography x-ray system.
Definition Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Product CodeOAS
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
TROPHY
  SUBSTANTIALLY EQUIVALENT 1

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