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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controller, foot, handpiece and cord
Regulation Description Dental handpiece and accessories.
Product CodeEBW
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 33
Burn of device or device component 13
Retraction problem 4
Device operates differently than expected 2
Device or device component damaged by another device 2
Failure to power-up 1
Material separation 1
Delivery system failure 1
Failure to shut off 1
Break 1
Data Issue 1
Insufficient cooling 1
Total Device Problems 61

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 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Nobel Biocare Usa Llc II Nov-13-2013

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