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 K111231
Device Name PANOURA 18S
Applicant
The Yoshida Dental Mfg. Co., Ltd.
4-1-17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Applicant Contact FUMIAKI KANAI
Correspondent
The Yoshida Dental Mfg. Co., Ltd.
4-1-17 Hongo, Bunkyo-Ku
Tokyo,  JP 113-0033
Correspondent Contact FUMIAKI KANAI
Regulation Number872.1800
Classification Product Code
MUH  
Date Received05/02/2011
Decision Date 07/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-