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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Product CodeLQY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect measurement 55
Device operates differently than expected 4
Incorrect or inadequate result 3
Material separation 1
Inappropriate shock 1
Measurement system incompatibility 1
Component falling 1
False reading from device non-compliance 1
Total Device Problems 67

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