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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handpiece, contra- and right-angle attachment, dental
Regulation Description Dental handpiece and accessories.
Product CodeEGS
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
MICRO-MEGA
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 132
Burn of device or device component 21
Total Device Problems 153

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