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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device toothbrush, powered
Regulation Description Powered toothbrush.
Product CodeJEQ
Regulation Number 872.6865
Device Class 1


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHN O. BUTLER CO.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1
US DENTEK CORP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 49
No code available 23
No Known Device Problem 21
Detachment of device or device component 10
Detachment of device component 9
Loose or intermittent connection 7
Fire 2
Vibration 2
Temperature issue 2
No Information 2
Component falling 2
Product quality issue 2
Slippage of device or device component 1
Sticking 1
Use of Device Issue 1
Crack 1
Burst 1
Mechanical jam 1
Overheating of device or device component 1
Total Device Problems 138

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Brushpoint Innovations, Inc. II Mar-18-2011
2 Church & Dwight Inc II Jan-25-2012
3 Ranir Corporation II Jan-17-2014

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