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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, dental, with operative unit
Regulation Description Dental chair and accessories.
Product CodeKLC
Regulation Number 872.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 18
KAVO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 A-Dec Inc II Jun-25-2015
2 Pelton & Crane Company III Apr-09-2010
3 Pelton & Crane Company II Apr-01-2010

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