• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name unit, x-ray, extraoral with timer
510(k) Number K122582
Device Name DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
Original Applicant
DENTERPRISE INTERNATIONAL, INC.
110 east granada blvd
ormond beach,  FL  32176
Original Contact claude berthoin
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/23/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-