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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device post, root canal
Regulation Description Root canal post.
Product CodeELR
Regulation Number 872.3810
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 4
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 4
Fracture 3
Material integrity issue 2
Normal 1
Device, or device fragments remain in patient 1
Tip breakage 1
Device operates differently than expected 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Dentsply Worldwide Headqrt II Apr-28-2009

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