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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, operating, dental
Regulation Description Dental operating light.
Product CodeEAZ
Regulation Number 872.4630
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Installation-related problem 8
Device maintenance issue 3
Use of Device Issue 2
Break 2
Defective item 1
Detachment of device or device component 1
Mechanical issue 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Dental Equipment LLC II Jul-15-2011
2 Dental Equipment LLC II Jul-12-2007
3 Pelton & Crane / Marus / DCI Equipment / KaVo II Mar-28-2016

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