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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, air-powered, dental
Regulation Description Dental handpiece and accessories.
Product CodeEFB
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 19
BIOLASE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLOCK
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
KAVO
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL POLYMERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 5
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 3
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 4
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI DENTAL INSTRUMENT FACTORY
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
STAR DENTAL MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 257
Detachment of device component 29
Dent in material 26
Detachment of device or device component 16
Material separation 13
Device maintenance issue 9
Use of Device Issue 8
Mechanical issue 7
Device handling issue 4
Break 3
Electrical issue 2
Migration of device or device component 2
Failure to service 2
Maintenance does not comply to manufacturers recommendations 2
Misassembled by Users 2
Improper or incorrect procedure or method 2
Component(s), overheating of 2
Device operates differently than expected 2
Dislodged or dislocated 2
Installation-related problem 1
Insufficient cooling 1
Decoupling 1
Device Issue 1
No Information 1
Temperature issue 1
Inadequate service 1
Misconnection 1
Unintended ejection 1
Fire 1
Handpiece detachment 1
Leak 1
Air leak 1
Component falling 1
Total Device Problems 404

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

Recalls
Manufacturer Recall Class Date Posted
1 MTI Precision Products LLC. II Jul-12-2014
2 Nakanishi Inc. II Aug-26-2016

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