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 Implant, Endosseous, Root-Form
510(k) Number K173975
Device Name UF(II) Wide Fixture
Applicant
DIO Corporation
66, Centum seo-ro
Haeundae-gu
Busan,  KR 48058
Applicant Contact Jiae Park
Correspondent
DIO USA
3470 Wilshire Blvd, #620
Los Angeles,  CA  90010
Correspondent Contact Peter Kang
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/29/2017
Decision Date 06/01/2018
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
-
-