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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device crown and bridge, temporary, resin
Regulation Description Temporary crown and bridge resin.
Product CodeEBG
Regulation Number 872.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 6
KAVO
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 4
KULZER
  SUBSTANTIALLY EQUIVALENT 2
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 5
Malposition of device 4
Patient-device incompatibility 4
Device operates differently than expected 2
Failure to deploy 2
Fracture 2
Difficult to position 2
No Known Device Problem 2
Defective item 2
Break 1
Size incorrect for patient 1
Defective component 1
Structural problem 1
Device-device incompatibility 1
Total Device Problems 30

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 1 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 Jeneric/Pentron II Dec-03-2009

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