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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 530
Detachment of device component 77
Temperature issue 59
No Information 36
Burn of device or device component 21
Detachment of device or device component 20
Dent in material 16
Mechanical issue 14
Failure to service 9
Component falling 6
Device maintenance issue 5
Device operates differently than expected 3
Use of Device Issue 2
Corrosion 2
Maintenance does not comply to manufacturers recommendations 2
Device handling issue 2
No Known Device Problem 2
Material deformation 1
Malposition of device 1
Disassembly 1
Fracture 1
Break 1
Improper or incorrect procedure or method 1
Component missing 1
Sticking 1
Device or device component damaged by another device 1
Dislodged or dislocated 1
Expulsion 1
Total Device Problems 817

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