Osstem Implant Co., Ltd. - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
62 devices
Cleared
Oct 28, 2016
Link Abutment for CEREC
Dental
246d
Cleared
Oct 17, 2016
OSSTEM Implant System
Dental
129d
Cleared
Sep 21, 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
Dental
131d
Cleared
Aug 21, 2014
SB ANCHOR
Dental
164d
Cleared
Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
Dental
174d
Cleared
Jan 10, 2014
ET PROSTHETIC SYSTEM
Dental
304d
Cleared
Sep 18, 2013
SMARTBUILDER SYSTEM (SB1)
Dental
175d
Cleared
Apr 26, 2013
MULTI ANGLED ABUTMENT
Dental
140d
Cleared
Jan 07, 2013
TS IMPLANT SYSTEM
Dental
221d
Cleared
Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
Dental
169d
Cleared
Nov 29, 2012
TS FIXTURE SYSTEM
Dental
143d
Cleared
Nov 16, 2012
MS SA IMPLANT SYSTEM
Dental
116d
Cleared
Oct 03, 2012
SMARTBUILDER SYSTEM
Dental
187d
Cleared
Aug 10, 2012
ET/SS IMPLANT SYSTEM
Dental
143d
Cleared
Oct 03, 2011
PROSTHETIC SYSTEM
Dental
243d
Cleared
Mar 25, 2011
ORTHODONTIC SCREW
Dental
156d
Cleared
Aug 17, 2010
HS/HG PROSTHETIC SYSTEM
Dental
202d
Cleared
Mar 03, 2010
GS III SYSTEM
Dental
313d
Cleared
Feb 18, 2010
HG II SHORT FIXTURE SYSTEM
Dental
253d
Cleared
May 01, 2009
HS II SHORT FIXTURE SYSTEM
Dental
144d
Cleared
Feb 02, 2009
MS SYSTEM
Dental
110d
Cleared
Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
Dental
161d
Cleared
Oct 14, 2008
GS III FIXTURE SYSTEM
Dental
69d
Cleared
Sep 03, 2008
MS SYSTEM (NARROW RIDGE)
Dental
184d
Cleared
Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
Dental
89d