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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 8
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 37
INNOVA
  SUBSTANTIALLY EQUIVALENT 3
KEYSTONE DENTAL
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LEIBINGER
  SUBSTANTIALLY EQUIVALENT 1
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 23
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 2
MONDEAL MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 26
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 5
STERNGOLD
  SUBSTANTIALLY EQUIVALENT 7
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 39
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 5035
Osseointegration issue 1136
Loss of osseointegration 779
Fracture 266
Implant, removal of 136
No Information 114
No Known Device Problem 63
Implant Mobility NOS (Not otherwise specified) 63
Mechanical issue 48
Packaging issue 43
Use of Device Issue 37
Improper or incorrect procedure or method 33
Implant overload 28
Device Issue 14
Product quality issue 14
Failure to separate 10
Break 9
Intended use for traditional use 9
Not Applicable 9
Patient-device incompatibility 8
Traditional use 8
Migration of device or device component 8
Absorption 7
Extrusion 7
Slippage of device or device component 6
User used incorrect product for intended use 5
Failure to deploy 5
Difficult to insert 4
Size incorrect for patient 4
Positioning Issue 4
Malposition of device 4
Device operates differently than expected 3
Manufacturing or shipping issue associated with device 3
Defective component 3
Difficult to remove 3
Failure to interrogate 2
Failure to Adhere or Bond 2
Component missing 2
Device inoperable 2
Component or accessory incompatibility 2
Device-device incompatibility 2
Dislodged or dislocated 1
Foreign material present in device 1
Incompatibility problem 1
Torn material 1
Misassembled by Users 1
Device packaging compromised 1
Folding Issue 1
Material deformation 1
Material Distortion 1
No code available 1
Defective item 1
Structural problem 1
Unexpected therapeutic results 1
Explanted 1
Detachment of device component 1
Component falling 1
Difficult to deploy 1
Material fragmentation 1
Sensing intermittently 1
Difficult to position 1
Total Device Problems 7960

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 4 0 1 3 1 5 2 10 5 11 8
Class III 4 3 0 1 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3m Imtec Corporation II May-27-2010
2 Ace Surgical Supply Co., Inc. II Apr-17-2017
3 Anthogyr II Sep-08-2016
4 BioHorizons Implant Systems Inc II Dec-07-2015
5 BioHorizons Implant Systems Inc II May-12-2015
6 BioHorizons Implant Systems Inc II Feb-20-2014
7 BioHorizons Implant Systems Inc II Dec-19-2012
8 BioHorizons Implant Systems Inc II Nov-04-2010
9 BioHorizons Implant Systems Inc III May-11-2007
10 BioHorizons Implant Systems Inc III Apr-13-2007
11 Biomedicare, Inc. II Jul-23-2007
12 Biomet 3i II Sep-18-2007
13 Biomet 3i II Jun-19-2007
14 Biomet 3i II Jun-14-2007
15 Biomet 3i III May-16-2007
16 Biomet 3i, Inc. III Jun-25-2015
17 Biomet 3i, LLC II Mar-29-2017
18 Biomet 3i, LLC II Sep-19-2016
19 Biomet 3i, LLC II Aug-12-2016
20 Biomet 3i, LLC II Jan-06-2016
21 Biomet 3i, LLC II Apr-10-2015
22 Biomet 3i, LLC II Apr-15-2014
23 Biomet 3i, LLC II Sep-16-2013
24 Biomet 3i, LLC II Aug-13-2013
25 Biomet 3i, LLC II Nov-16-2012
26 Biomet 3i, LLC II Oct-23-2012
27 Biomet 3i, LLC II Jun-20-2012
28 Biomet 3i, LLC II Nov-08-2011
29 Biomet 3i, LLC II Feb-22-2010
30 Implant Direct Sybron Manufacturing, LLC II May-22-2017
31 Implant Direct Sybron Manufacturing, LLC II Jan-28-2017
32 Implant Direct Sybron Manufacturing, LLC II Jan-09-2017
33 Implant Direct Sybron Manufacturing, LLC II Aug-02-2016
34 Implant Direct Sybron Manufacturing, LLC II Mar-28-2016
35 Instradent USA, Inc. II Dec-22-2014
36 Keystone Dental Inc II Apr-13-2017
37 Keystone Dental Inc II Oct-21-2016
38 Medtronic Navigation, Inc. II Aug-02-2016
39 Nobel Biocare USA LLC III Sep-19-2008
40 Nobel Biocare Usa Llc II Jul-19-2016
41 Nobel Biocare Usa Llc II Apr-13-2015
42 Pro-Dex Inc dba Dyna-Dent III Mar-26-2010
43 Southern Implants, Inc II Mar-12-2015
44 Straumann Manufacturing Inc. III Sep-16-2008
45 Straumann Manufacturing, Inc. II Aug-12-2016
46 Straumann USA, LLC II Nov-06-2014
47 Straumann USA, LLC II Oct-23-2014
48 Thommen Medical, AG III Jul-24-2007
49 Zest Anchors Inc III Dec-01-2008
50 Zest Anchors LLC II Feb-06-2014
51 Zimmer Dental Inc II Sep-22-2017
52 Zimmer Dental Inc II Apr-14-2017
53 Zimmer Dental Inc II Feb-09-2016
54 Zimmer Dental Inc II Oct-30-2014
55 Zimmer Dental Inc II Jan-28-2014
56 Zimmer Inc. II May-10-2012
57 Zimmer Inc. II Dec-10-2009
58 Zimmer, Inc. II Aug-02-2014
59 Zimmer, Inc. II Jul-14-2014

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