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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drill, dental, intraoral
Regulation Description Intraoral dental drill.
Product CodeDZA
Regulation Number 872.4130
Device Class 1


Premarket Reviews
ManufacturerDecision
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 10
Fracture 4
Overheating of device or device component 2
Detachment of device component 2
Component falling 1
Material separation 1
Dent in material 1
Total Device Problems 21

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Sep-01-2009

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