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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device file, pulp canal, endodontic
Regulation Description Dental hand instrument.
Product CodeEKS
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICRO-MEGA
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT 2
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1
US DENTEK CORP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 42
Material separation 11
Fracture 3
Material discolored 2
Incompatibility problem 2
No Known Device Problem 1
Packaging issue 1
No Information 1
No code available 1
Unknown (for use when the device problem is not known) 1
Detachment of device or device component 1
Device operates differently than expected 1
Total Device Problems 67

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

Recalls
Manufacturer Recall Class Date Posted
1 Ormco Corporation III Mar-06-2012
2 Ormco/Sybronendo II Feb-01-2013

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