• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name x-ray, tomography, computed, dental
510(k) Number K120948
Device Name PREXION 3D
Original Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
1-3-6 kotobashi, sumida-ku
tokyo,  JP 130-8516
Original Contact hidenori watanabe
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/29/2012
Decision Date 12/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-