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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 5
ASTRA
  SUBSTANTIALLY EQUIVALENT 3
BIOHORIZONS IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
DENTIUM CO.
  SUBSTANTIALLY EQUIVALENT 3
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 27
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 32
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Detachment of device component 1
Fracture 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 4 1
Class III 0 3 0 0 1 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 Aug-24-2012
5 Biomet 3i, LLC II Aug-08-2012
6 Biomet 3i, LLC II Apr-25-2012
7 Biomet 3i, LLC II Nov-03-2011
8 Biomet 3i, LLC III Jul-26-2011
9 Keystone Dental Inc II Mar-08-2013
10 Straumann USA, LLC II Aug-08-2012

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