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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adhesive, bracket and tooth conditioner, resin
Regulation Description Bracket adhesive resin and tooth conditioner.
Product CodeDYH
Regulation Number 872.3750
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 6
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 4
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 9
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Patient-device incompatibility 2
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 1 0 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 Ormco Corporation II Apr-10-2008

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