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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device activator, ultraviolet, for polymerization
Regulation Description Ultraviolet activator for polymerization.
Product CodeEBZ
Regulation Number 872.6070
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KAVO
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 5
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LUMALITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 4
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Output issue 18
Device expiration issue 14
Device sensing issue 4
Fire 3
Use of Device Issue 3
Improper or incorrect procedure or method 1
Device Issue 1
Unable to confirm conditions of use 1
Device disinfection or sterilization issue 1
Device operates differently than expected 1
Instruction for use issue 1
Power Conditioning Issue 1
Smoking 1
Break 1
No Information 1
Total Device Problems 52

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

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar Vivadent, Inc. II Jun-09-2014
2 O'Ryan Industries Inc II May-09-2012

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