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 Locator, Root Apex
510(k) Number K112508
Device Name I-ROOT 100
Applicant
S-Denti Co., Ltd.
Valley 6,481-4
Gasan-Dong Geumcheon-Gu
Tae Kye Nam,  KR 153-803
Applicant Contact TAE K NAM
Correspondent
S-Denti Co., Ltd.
Valley 6,481-4
Gasan-Dong Geumcheon-Gu
Tae Kye Nam,  KR 153-803
Correspondent Contact TAE K NAM
Classification Product Code
LQY  
Date Received08/30/2011
Decision Date 06/19/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-