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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, contra- and right-angle attachment, dental
Regulation Description Dental handpiece and accessories.
Product CodeEGS
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
MICRO-MEGA
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 275
No Information 36
Burn of device or device component 21
Detachment of device component 18
Detachment of device or device component 10
Temperature issue 7
Component falling 6
Mechanical issue 4
Device operates differently than expected 3
Maintenance does not comply to manufacturers recommendations 2
Device maintenance issue 2
Corrosion 2
Disassembly 1
Sticking 1
Component missing 1
No Known Device Problem 1
Dislodged or dislocated 1
Expulsion 1
Total Device Problems 392

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

Recalls
Manufacturer Recall Class Date Posted
1 Bien Air Dental SA II Sep-21-2015

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