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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device material, impression
Regulation Description Impression material.
Product CodeELW
Regulation Number 872.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 5
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 2
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 10
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 7
KULZER
  SUBSTANTIALLY EQUIVALENT 15
PACIFIC RIM DENTAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 4
Unintended movement 2
Material separation 2
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kerr Corporation II Nov-08-2012
2 Sybron Dental Specialties III Mar-02-2012
3 Ultradent Products, Inc. III Feb-13-2013

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