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

Cleared Apr 20, 2017

K3

K152830 · EIA

Dental · 569d

Cleared Feb 02, 2017

US SA Implant System

K161103 · DZE

Dental · 289d

Cleared Dec 21, 2016

Orthodontic Screw

K161197 · OAT

Dental · 237d

Cleared Dec 05, 2016

Transfer & Angled Abutment

K153015 · NHA

Dental · 417d

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 26, 2014

PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)

K141497 · EHD

Radiology · 81d

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 May 16, 2013

PORTABLE X-RAY SYSTEM

K122124 · EHD

Radiology · 302d

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