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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 7
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 2
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 10
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 8
KULZER
  SUBSTANTIALLY EQUIVALENT 15
PACIFIC RIM DENTAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SYBRON
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Patient-device incompatibility 23
No Known Device Problem 19
Unintended movement 2
No code available 2
Material separation 2
Use of Device Issue 1
Improper or incorrect procedure or method 1
Obstruction within device 1
Device clogged 1
Entrapment of device or device component 1
User used incorrect product for intended use 1
Material rigid or stiff 1
Device handling issue 1
Torn material 1
Device operates differently than expected 1
Infusion or flow issue 1
Total Device Problems 59

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

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-18-2013
2 Kerr Corporation II Nov-08-2012
3 Sybron Dental Specialties III Mar-02-2012
4 Ultradent Products, Inc. III Feb-13-2013

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