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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device caries detector, laser light, transmission
Regulation Description Laser fluorescence caries detection device.
Product CodeNTK
Regulation Number 872.1745
Device Class 2


Premarket Reviews
ManufacturerDecision
ELECTRO-OPTICAL SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
KAVO
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 1
Total Device Problems 1

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