• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 216
Dent in material 26
Detachment of device component 19
Material separation 13
Detachment of device or device component 11
Device maintenance issue 8
Use of Device Issue 7
Device handling issue 4
Dislodged or dislocated 3
Mechanical issue 3
Break 3
Component falling 2
Component(s), overheating of 2
Electrical issue 2
Misassembled by Users 2
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
Unintended ejection 1
Fire 1
Handpiece detachment 1
Leak 1
Insufficient cooling 1
Decoupling 1
Air leak 1
Misconnection 1
Failure to service 1
Inadequate service 1
Total Device Problems 337

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 1 0 1
Class III 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

-
-