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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 249
No Information 36
Burn of device or device component 21
Detachment of device component 18
Detachment of device or device component 9
Temperature issue 6
Component falling 6
Mechanical issue 3
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 363

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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