Medical Device Manufacturer · US , Waltham , MA

Astra Tech, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1994
28
Total
28
Cleared
0
Denied

FDA 510(k) Regulatory Record - Astra Tech, Inc. Dental

24 devices
1-24 of 24
Cleared Jul 05, 2012
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN...
K120338 · NHA
Dental · 153d
Cleared Mar 01, 2012
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS...
K113003 · NHA
Dental · 146d
Cleared Dec 01, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
K112138 · NHA
Dental · 128d
Cleared Jun 10, 2011
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
K110356 · NHA
Dental · 123d
Cleared Jun 10, 2011
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
K110640 · NHA
Dental · 98d
Cleared Apr 08, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
K103759 · NHA
Dental · 106d
Cleared Aug 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT,...
K101004 · NHA
Dental · 126d
Cleared Apr 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS...
K093780 · NHA
Dental · 128d
Cleared Dec 22, 2009
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT,...
K093483 · NHA
Dental · 43d
Cleared Sep 28, 2009
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE...
K091920 · NHA
Dental · 90d
Cleared Apr 15, 2009
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL...
K083871 · NHA
Dental · 107d
Cleared Oct 07, 2008
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED...
K081666 · NHA
Dental · 116d
Cleared Apr 27, 2007
OSSEOSPEED 4.0S-6MM, MODEL 24619
K063779 · DZE
Dental · 127d
Cleared Mar 24, 2006
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
K053384 · DZE
Dental · 109d
Cleared Aug 09, 2004
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K041492 · DZE
Dental · 66d
Cleared Jun 10, 2003
ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
K024111 · DZE
Dental · 179d
Cleared Nov 07, 2002
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
K023631 · NHA
Dental · 9d
Cleared Jan 04, 2001
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K002513 · DZE
Dental · 142d
Cleared Jul 15, 1999
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
K990304 · DZE
Dental · 164d
Cleared Jun 25, 1999
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
K991053 · DZE
Dental · 87d
Cleared Nov 19, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974738 · DZE
Dental · 335d
Cleared Mar 24, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737 · DZE
Dental · 95d
Cleared Mar 19, 1998
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698 · DZE
Dental · 24d
Cleared Feb 08, 1994
ASTRA TECH IMPLANTS-DENTAL SYSTEM
K931767 · DZE
Dental · 306d
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