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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, fluorescence caries detection
Product CodeNBL
Regulation Number 872.1745
Device Class 2


Premarket Reviews
ManufacturerDecision
3SHAPE TRIOS A/S
  SUBSTANTIALLY EQUIVALENT 1
GOOD DOCTORS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

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