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 System, X-Ray, Extraoral Source, Digital
510(k) Number K151707
Device Name EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro, 1-Gil
Hwaseong-Si,  KR 445-170
Applicant Contact KEVIN KIM
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/24/2015
Decision Date 07/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-