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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 230
Dent in material 26
Detachment of device component 21
Detachment of device or device component 14
Material separation 13
Device maintenance issue 8
Use of Device Issue 7
Device handling issue 4
Mechanical issue 4
Break 3
Dislodged or dislocated 3
Misassembled by Users 2
Failure to service 2
Component falling 2
Component(s), overheating of 2
Electrical issue 2
Unintended ejection 1
Fire 1
Handpiece detachment 1
Leak 1
Insufficient cooling 1
Decoupling 1
Inadequate service 1
Air leak 1
Misconnection 1
No Information 1
Improper or incorrect procedure or method 1
Device Issue 1
Installation-related problem 1
Maintenance does not comply to manufacturers recommendations 1
Temperature issue 1
Total Device Problems 358

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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