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 K172640
Device Name Dentium Implantium & SuperLine Prosthetics
Applicant
Dentium Co., Ltd.
150, Eondong-ro, Giheung-gu
Yongin-si,  KR 16985
Applicant Contact Sangpil Yoon
Correspondent
Dentium Co., Ltd.
150, Eondong-ro, Giheung-gu
Yongin-si,  KR 16985
Correspondent Contact Sangpil Yoon
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/01/2017
Decision Date 05/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-