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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 2
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 2
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 135
Dent in material 15
Retraction problem 5
Device handling issue 4
Device operates differently than expected 3
Device or device component damaged by another device 3
Detachment of device component 3
Fluid leak 2
Inappropriate shock 2
Failure to calibrate 2
Device Issue 2
Overfill 1
Maintenance does not comply to manufacturers recommendations 1
Temperature issue 1
No code available 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Material separation 1
Failure to service 1
Patient-device incompatibility 1
Calibration issue 1
Detachment of device or device component 1
Device maintenance issue 1
Difficult to remove 1
Incorrect display 1
Bent 1
Burn of device or device component 1
Total Device Problems 192

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