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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, dental
Regulation Description Dental bur.
Product CodeEJL
Regulation Number 872.3240
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Bent 2
Break 2
Burrs, breakage of 2
Tip breakage 2
Fracture 2
Material separation 1
Size incorrect for patient 1
Detachment of device or device component 1
Material twisted 1
No Known Device Problem 1
No Information 1
Detachment of device component 1
Failure to deploy 1
Total Device Problems 18

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 Biomet Microfixation, Inc. II Sep-08-2009

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