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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bracket, plastic, orthodontic
Regulation Description Orthodontic plastic bracket.
Product CodeDYW
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 9
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Loose or intermittent connection 1
Failure to osseointegrate 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ormco Corporation III Nov-16-2011
2 Ormco/Sybronendo II Apr-04-2014

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