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 K173570
Device Name SD Abutment
Applicant
Surgident Co., Ltd.
#209-210, Woolim Lion'S Valley, 27,
Dunchon-Daero 457beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13229
Applicant Contact Ju Youn Choi
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/20/2017
Decision Date 05/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-