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 Implant, Endosseous, Root-Form
510(k) Number K222778
Device Name Osstem Implant System
Applicant
Osstem Implant Co., Ltd.
66-16, Bansong-Ro 513beon-Gil, Haeundae-Gu,
Busan,  KR 48002
Applicant Contact Seungju Kang
Correspondent
Hiossen, Inc.
85 Ben Fariless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/14/2022
Decision Date 09/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-