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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device abutment, implant, dental, endosseous
Regulation Description Endosseous dental implant abutment.
Definition To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Product CodeNHA
Regulation Number 872.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTATEC GMBH
  SUBSTANTIALLY EQUIVALENT 9
ASTRA
  SUBSTANTIALLY EQUIVALENT 3
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
DENTIUM CO.
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
INNOVA
  SUBSTANTIALLY EQUIVALENT 1
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 37
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 2
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 46
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 19

Device Problems
Failure to osseointegrate 135
Fracture 134
Not Applicable 36
Break 20
Difficult to remove 10
No Information 10
Detachment of device or device component 4
Use of Device Issue 4
No Known Device Problem 3
Loose or intermittent connection 3
Mechanical issue 3
Failure to deploy 2
Entrapment of device or device component 2
Loss of or failure to bond 2
Nonstandard device or device component 2
Improper or incorrect procedure or method 2
Size incorrect for patient 2
Device handling issue 2
Defective item 2
Application program issue 1
Device operates differently than expected 1
Dislodged or dislocated 1
No code available 1
Data Issue 1
Unintended movement 1
Slippage of device or device component 1
Device inoperable 1
Loss of osseointegration 1
Material separation 1
Detachment of device component 1
Migration of device or device component 1
Difficult to insert 1
Total Device Problems 391

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 0 0 0 0 1 4 3 2 2 2 0
Class III 0 3 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i III Jan-17-2008
2 Biomet 3i, Inc. III Mar-29-2008
3 Biomet 3i, Inc. III Mar-28-2008
4 Biomet 3i, LLC II Dec-20-2016
5 Biomet 3i, LLC II Aug-12-2016
6 Biomet 3i, LLC II Sep-11-2015
7 Biomet 3i, LLC II Sep-05-2014
8 Biomet 3i, LLC II Mar-17-2014
9 Biomet 3i, LLC II Aug-24-2012
10 Biomet 3i, LLC II Aug-08-2012
11 Biomet 3i, LLC II Apr-25-2012
12 Biomet 3i, LLC II Nov-03-2011
13 Biomet 3i, LLC III Jul-26-2011
14 Camlog Usa II Sep-16-2013
15 Implant Direct Sybron Manufacturing, LLC II Dec-08-2015
16 Keystone Dental Inc II Mar-08-2013
17 Southern Implants, Inc II Nov-22-2013
18 Straumann USA, LLC II Aug-08-2012

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