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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bracket, ceramic, orthodontic
Regulation Description Orthodontic plastic bracket.
Definition An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new postion. (the current classification only specifies plastic brackets. Confusion exists as to whether ceramic brackets are regulated.)
Product CodeNJM
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Improper or incorrect procedure or method 1
No Known Device Problem 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Ultradent Products, Inc. III Dec-11-2013

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