Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K161689
Device Name OSSTEM Implant System - Abutment
Applicant
OSSTEM IMPLANT Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan,  KR 612-070
Applicant Contact Hee Kwon
Correspondent
HiOSSEN Inc.
85 Ben Fairless Dr.
Fairless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/20/2016
Decision Date 05/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-