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 K100245
Device Name HS/HG PROSTHETIC SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Applicant Contact PATRICK LIM
Correspondent
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact PATRICK LIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/27/2010
Decision Date 08/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-