Medical Device Manufacturer · KR , Busan

Osstem Implant Co., Ltd. - FDA 510(k) Cleared Devices

68 submissions · 68 cleared · Since 2006
68
Total
68
Cleared
0
Denied
62 devices
26-50 of 62
Cleared Oct 28, 2016
Link Abutment for CEREC
K160519 · NHA
Dental · 246d
Cleared Oct 17, 2016
OSSTEM Implant System
K161604 · DZE
Dental · 129d
Cleared Sep 21, 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · ELW
Dental · 131d
Cleared Aug 21, 2014
SB ANCHOR
K140600 · NHA
Dental · 164d
Cleared Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
K140507 · NHA
Dental · 174d
Cleared Jan 10, 2014
ET PROSTHETIC SYSTEM
K130662 · NHA
Dental · 304d
Cleared Sep 18, 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · JEY
Dental · 175d
Cleared Apr 26, 2013
MULTI ANGLED ABUTMENT
K123755 · NHA
Dental · 140d
Cleared Jan 07, 2013
TS IMPLANT SYSTEM
K121585 · DZE
Dental · 221d
Cleared Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
K121843 · NHA
Dental · 169d
Cleared Nov 29, 2012
TS FIXTURE SYSTEM
K121995 · DZE
Dental · 143d
Cleared Nov 16, 2012
MS SA IMPLANT SYSTEM
K122171 · DZE
Dental · 116d
Cleared Oct 03, 2012
SMARTBUILDER SYSTEM
K120951 · JEY
Dental · 187d
Cleared Aug 10, 2012
ET/SS IMPLANT SYSTEM
K120847 · DZE
Dental · 143d
Cleared Oct 03, 2011
PROSTHETIC SYSTEM
K110308 · NHA
Dental · 243d
Cleared Mar 25, 2011
ORTHODONTIC SCREW
K103105 · OAT
Dental · 156d
Cleared Aug 17, 2010
HS/HG PROSTHETIC SYSTEM
K100245 · NHA
Dental · 202d
Cleared Mar 03, 2010
GS III SYSTEM
K091208 · DZE
Dental · 313d
Cleared Feb 18, 2010
HG II SHORT FIXTURE SYSTEM
K091678 · DZE
Dental · 253d
Cleared May 01, 2009
HS II SHORT FIXTURE SYSTEM
K083633 · DZE
Dental · 144d
Cleared Feb 02, 2009
MS SYSTEM
K083067 · DZE
Dental · 110d
Cleared Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786 · NHA
Dental · 161d
Cleared Oct 14, 2008
GS III FIXTURE SYSTEM
K082213 · DZE
Dental · 69d
Cleared Sep 03, 2008
MS SYSTEM (NARROW RIDGE)
K080594 · DZE
Dental · 184d
Cleared Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575 · NHA
Dental · 89d
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