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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
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 96
Dent in material 19
Device maintenance issue 7
Use of Device Issue 2
Detachment of device component 2
Component(s), overheating of 2
Insufficient cooling 1
Fire 1
Handpiece detachment 1
Inadequate service 1
Device handling issue 1
Total Device Problems 133

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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