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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, implant, dental, endosseous
Regulation Description Endosseous dental implant accessories.
Product CodeNDP
Regulation Number 872.3980
Device Class 1

Device Problems
No Known Device Problem 80
Fracture 36
Failure to deploy 13
Failure to Adhere or Bond 8
Break 7
Product quality issue 7
Blockage within device or device component 6
Manufacturing or shipping issue associated with device 6
Improper or incorrect procedure or method 4
Material torqued 4
No code available 4
Bent 4
Difficult to insert 4
Detachment of device component 3
Difficult to position 2
Sticking 2
Use of Device Issue 2
Not Applicable 2
No Information 2
Material integrity issue 2
Defective item 2
Malposition of device 1
Detachment of device or device component 1
Device markings issue 1
Device operates differently than expected 1
Dislodged or dislocated 1
Failure to separate 1
Mechanical jam 1
Device handling issue 1
Difficult to remove 1
User used incorrect product for intended use 1
Instruction for use issue 1
Mechanical issue 1
Component incompatible 1
Material fragmentation 1
Total Device Problems 214

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 1 0 0 1 1 0 5 1
Class III 0 0 0 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Jan-06-2016
2 Biomet 3i, LLC II Dec-31-2015
3 Biomet 3i, LLC II Nov-12-2015
4 Innovative Implant Technology II Jan-09-2009
5 Keystone Dental Inc II Mar-20-2013
6 Nobel Biocare Usa Llc II Jul-15-2015
7 Straumann Manufacturing Inc. III Nov-04-2010
8 Straumann Manufacturing Inc. III Aug-06-2010
9 Straumann USA, LLC II Jan-15-2015
10 Straumann USA, LLC II Mar-30-2012
11 Zimmer Dental Inc II Feb-12-2015

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