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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, endosseous, root-form
Regulation Description Endosseous dental implant.
Product CodeDZE
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTATEC GMBH
  SUBSTANTIALLY EQUIVALENT 4
BICON
  SUBSTANTIALLY EQUIVALENT 11
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 22
BIOLOK INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 6
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLLAGEN
  SUBSTANTIALLY EQUIVALENT 5
DENTIUM CO.
  SUBSTANTIALLY EQUIVALENT 6
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 37
INNOVA
  SUBSTANTIALLY EQUIVALENT 3
KEYSTONE DENTAL
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LEIBINGER
  SUBSTANTIALLY EQUIVALENT 1
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 40
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 2
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 23
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 5
STERNGOLD
  SUBSTANTIALLY EQUIVALENT 7
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 38
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SYBRON
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 18

Device Problems
Failure to osseointegrate 3519
Osseointegration issue 566
Loss of osseointegration 461
Fracture 161
Implant, removal of 136
Implant Mobility NOS (Not otherwise specified) 62
No Known Device Problem 53
Use of Device Issue 36
Improper or incorrect procedure or method 31
Implant overload 28
Not Applicable 9
No Information 9
Intended use for traditional use 9
Patient-device incompatibility 8
Migration of device or device component 8
Traditional use 8
Extrusion 7
Absorption 7
Slippage of device or device component 6
Device Issue 5
Size incorrect for patient 4
User used incorrect product for intended use 4
Difficult to insert 4
Break 3
Failure to interrogate 2
Difficult to remove 2
Device inoperable 2
Defective component 2
Device operates differently than expected 2
Malposition of device 2
Positioning Issue 2
Torn material 1
Packaging issue 1
Incompatibility problem 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material Distortion 1
Folding Issue 1
Structural problem 1
Defective item 1
Device packaging compromised 1
Device-device incompatibility 1
Dislodged or dislocated 1
Unexpected therapeutic results 1
Sensing intermittently 1
Product quality issue 1
Failure to Adhere or Bond 1
Difficult to position 1
Mechanical issue 1
Detachment of device component 1
Component falling 1
Explanted 1
Total Device Problems 5179

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 4 0 1 3 1 5 2 10 5 11
Class III 4 3 0 1 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 3m Imtec Corporation II May-27-2010
2 Anthogyr II Sep-08-2016
3 BioHorizons Implant Systems Inc II Dec-07-2015
4 BioHorizons Implant Systems Inc II May-12-2015
5 BioHorizons Implant Systems Inc II Feb-20-2014
6 BioHorizons Implant Systems Inc II Dec-19-2012
7 BioHorizons Implant Systems Inc II Nov-04-2010
8 BioHorizons Implant Systems Inc III May-11-2007
9 BioHorizons Implant Systems Inc III Apr-13-2007
10 Biomedicare, Inc. II Jul-23-2007
11 Biomet 3i II Sep-18-2007
12 Biomet 3i II Jun-19-2007
13 Biomet 3i II Jun-14-2007
14 Biomet 3i III May-16-2007
15 Biomet 3i, Inc. III Jun-25-2015
16 Biomet 3i, LLC II Sep-19-2016
17 Biomet 3i, LLC II Aug-12-2016
18 Biomet 3i, LLC II Jan-06-2016
19 Biomet 3i, LLC II Apr-10-2015
20 Biomet 3i, LLC II Apr-15-2014
21 Biomet 3i, LLC II Sep-16-2013
22 Biomet 3i, LLC II Aug-13-2013
23 Biomet 3i, LLC II Nov-16-2012
24 Biomet 3i, LLC II Oct-23-2012
25 Biomet 3i, LLC II Jun-20-2012
26 Biomet 3i, LLC II Nov-08-2011
27 Biomet 3i, LLC II Feb-22-2010
28 Implant Direct Sybron Manufacturing, LLC II Aug-02-2016
29 Implant Direct Sybron Manufacturing, LLC II Mar-28-2016
30 Instradent USA, Inc. II Dec-22-2014
31 Keystone Dental Inc II Oct-21-2016
32 Medtronic Navigation, Inc. II Aug-02-2016
33 Nobel Biocare USA LLC III Sep-19-2008
34 Nobel Biocare Usa Llc II Jul-19-2016
35 Nobel Biocare Usa Llc II Apr-13-2015
36 Pro-Dex Inc dba Dyna-Dent III Mar-26-2010
37 Southern Implants, Inc II Mar-12-2015
38 Straumann Manufacturing Inc. III Sep-16-2008
39 Straumann Manufacturing, Inc. II Aug-12-2016
40 Straumann USA, LLC II Nov-06-2014
41 Straumann USA, LLC II Oct-23-2014
42 Thommen Medical, AG III Jul-24-2007
43 Zest Anchors Inc III Dec-01-2008
44 Zest Anchors LLC II Feb-06-2014
45 Zimmer Dental Inc II Feb-09-2016
46 Zimmer Dental Inc II Oct-30-2014
47 Zimmer Dental Inc II Jan-28-2014
48 Zimmer Inc. II May-10-2012
49 Zimmer Inc. II Dec-10-2009
50 Zimmer, Inc. II Aug-02-2014
51 Zimmer, Inc. II Jul-14-2014

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