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 K230246
Device Name Dentis s-Clean SQ-SL Narrow Implant System
Applicant
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu
Daegu,  KR 42718
Applicant Contact EunJin Shin
Correspondent
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/30/2023
Decision Date 05/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-