FDA 510(k) Applications Submitted by OSSTEM IMPLANT CO.,LTD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K062030 |
07/18/2006 |
US SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K062051 |
07/19/2006 |
SS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K072871 |
10/09/2007 |
MS SYSTEM (PROVISIONAL) |
OSSTEM IMPLANT CO.,LTD |
| K063861 |
12/28/2006 |
GS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K072896 |
10/11/2007 |
GS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K080387 |
02/13/2008 |
HU II / HS II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K072959 |
10/19/2007 |
MS SYSTEM (DENTURE) |
OSSTEM IMPLANT CO.,LTD |
| K073465 |
12/10/2007 |
US/GS ULTRA WIDE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K080594 |
03/03/2008 |
MS SYSTEM (NARROW RIDGE) |
OSSTEM IMPLANT CO.,LTD |
| K080744 |
03/17/2008 |
HG II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K081078 |
04/16/2008 |
NT/IT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K091208 |
04/24/2009 |
GS III SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K081575 |
06/05/2008 |
HU/HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K082213 |
08/06/2008 |
GS III FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K083067 |
10/15/2008 |
MS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K083633 |
12/08/2008 |
HS II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K100245 |
01/27/2010 |
HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K110308 |
02/02/2011 |
PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K130662 |
03/12/2013 |
ET PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K120847 |
03/20/2012 |
ET/SS IMPLANT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K130840 |
03/27/2013 |
SMARTBUILDER SYSTEM (SB1) |
OSSTEM IMPLANT CO.,LTD |
| K120951 |
03/30/2012 |
SMARTBUILDER SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K121585 |
05/31/2012 |
TS IMPLANT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K141497 |
06/06/2014 |
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) |
OSSTEM IMPLANT CO.,LTD |
| K091678 |
06/10/2009 |
HG II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K121843 |
06/25/2012 |
NP-CAST ABUTMENT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K121995 |
07/09/2012 |
TS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K122124 |
07/18/2012 |
PORTABLE X-RAY SYSTEM |
OSSTEM IMPLANT CO.,LTD |
| K103105 |
10/20/2010 |
ORTHODONTIC SCREW |
OSSTEM IMPLANT CO.,LTD |
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