Company ยท US
Astra Tech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2013. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2013 | K121810 | OSSEOSPEED ANGLED ABUTMENT EV Astra Tech AB | NHA |
| Oct 31, 2012 | K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT Astra Tech, Inc. | EZD |
| Jul 31, 2012 | K120414 | OSSEOSPEED PLUS Astra Tech AB | DZE |
| Jul 5, 2012 | K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA Astra Tech, Inc. | NHA |
| Apr 17, 2012 | K113424 | LOFRIC SINGLE USE URINARY CATHETER Astra Tech AB | EZD |
| Mar 1, 2012 | K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... Astra Tech, Inc. | NHA |
| Dec 1, 2011 | K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT Astra Tech, Inc. | NHA |
| Sep 26, 2011 | K111287 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Jun 21, 2011 | K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT Astra Tech AB | NHA |
| Jun 10, 2011 | K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT Astra Tech, Inc. | NHA |
| Jun 10, 2011 | K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT Astra Tech, Inc. | NHA |
| Apr 8, 2011 | K103759 | ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT Astra Tech, Inc. | NHA |
| Feb 23, 2011 | K101732 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Aug 16, 2010 | K101004 | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Apr 16, 2010 | K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Dec 22, 2009 | K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Sep 28, 2009 | K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL Astra Tech, Inc. | NHA |
| Sep 22, 2009 | K091239 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Apr 15, 2009 | K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE Astra Tech, Inc. | NHA |
| Oct 7, 2008 | K081666 | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS Astra Tech, Inc. | NHA |
| Sep 17, 2008 | K080156 | OSSEOSPEED TM PROFILE SYSTEM Astra Tech AB | DZE |
| Apr 30, 2008 | K080396 | OSSEOSPEED NARROW Astra Tech AB | DZE |
| Oct 1, 2007 | K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT Astra Tech AB | NHA |
| Apr 27, 2007 | K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 Astra Tech, Inc. | DZE |
| Mar 24, 2006 | K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM Astra Tech, Inc. | DZE |
| May 5, 2005 | K050874 | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Dec 23, 2004 | K043241 | LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Aug 9, 2004 | K041492 | ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Jun 10, 2003 | K024111 | ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED Astra Tech, Inc. | DZE |
| Nov 7, 2002 | K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS Astra Tech, Inc. | NHA |
| Aug 23, 2001 | K012374 | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER Astra Tech, Inc. | GBM |
| Jan 4, 2001 | K002513 | ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Jul 15, 1999 | K990304 | MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Jun 25, 1999 | K991053 | ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) Astra Tech, Inc. | DZE |
| Nov 19, 1998 | K974738 | ASTRA TECH IMPLANT DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Mar 24, 1998 | K974737 | ASTRA TECH IMPLANT DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Mar 19, 1998 | K980698 | ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Feb 8, 1994 | K931767 | ASTRA TECH IMPLANTS-DENTAL SYSTEM Astra Tech, Inc. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||