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 K191127
Device Name Advanced Intermezzo Implant System
Applicant
MegaGen Implant Co., Ltd.
45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun
Daegu,  KR
Applicant Contact JiYoung Son
Correspondent
MegaGen Implant Co., Ltd.
45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun
Daegu,  KR
Correspondent Contact JiYoung Son
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/29/2019
Decision Date 10/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-