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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, endosseous, orthodontic
Regulation Description Endosseous dental implant.
Definition It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Product CodeOAT
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 2
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loose or intermittent connection 23
Device operates differently than expected 4
Bent 2
Break 2
Dislodged or dislocated 1
Total Device Problems 32

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 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 Ormco/Sybronendo II Sep-12-2013
2 Straumann USA LLC II Dec-04-2007

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