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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handpiece, direct drive, ac-powered
Regulation Description Dental handpiece and accessories.
Product CodeEKX
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 2
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 17
Detachment of device component 3
Device maintenance issue 1
Bent 1
Burn of device or device component 1
Difficult to remove 1
Device Issue 1
Overfill 1
Total Device Problems 26

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