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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bracket, metal, orthodontic
Regulation Description Orthodontic appliance and accessories.
Product CodeEJF
Regulation Number 872.5410
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 22
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Difficult to remove 3
Patient-device incompatibility 2
Difficult to insert 1
Improper or incorrect procedure or method 1
Total Device Problems 7

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 0 0 0 0 1 0 0
Class III 0 0 0 0 0 2 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ormco Corporation III Mar-01-2012
2 Ormco/Sybronendo II Apr-02-2014
3 Ormco/Sybronendo III Oct-23-2012
4 Ultradent Products, Inc. III Feb-22-2013

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