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 Resin, Root Canal Filling
510(k) Number K202015
Device Name White ENDOSEAL MTA
Applicant
Maruchi
2-208, Medical Industry Complex Bldg., 42-10,
Taejanggongdan-Gil
Wonju-Si,  KR 26311
Applicant Contact Sung Wook Jang
Correspondent
Maruchi
2-208, Medical Industry Complex Bldg., 42-10,
Taejanggongdan-Gil
Wonju-Si,  KR 26311
Correspondent Contact Sung Wook Jang
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/21/2020
Decision Date 03/24/2021
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
-
-