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 Unit, Operative Dental
510(k) Number K012505
Device Name SOPRO595 INTRA ORAL CAMERA
Applicant
Sopro
Pl. St. Christophe
Les Accates-La Valentine
Marseille,  FR F-13011
Applicant Contact PIERRE MONTILLOT
Correspondent
Sopro
Pl. St. Christophe
Les Accates-La Valentine
Marseille,  FR F-13011
Correspondent Contact PIERRE MONTILLOT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/03/2001
Decision Date 10/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-