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 Material, Tooth Shade, Resin
510(k) Number K251283
Device Name Once-Fil Flow
Applicant
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Applicant Contact Ku Da Hyeon
Correspondent
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Correspondent Contact Ku Da Hyeon
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/25/2025
Decision Date 06/06/2025
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
-
-