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 K210826
Device Name Healing Abutment, Cover Screw
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Applicant Contact You Jung Kim
Correspondent
Daegyeong Regulatory Affairs Institute
32, Innovalley-Ro
Daegu,  KR 41065
Correspondent Contact Hyo Eun Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/19/2021
Decision Date 02/03/2022
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
-
-