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 Implant, Endosseous, Root-Form
510(k) Number K090716
Device Name BEGO SEMADOS S-LINE
Applicant
Bego Implant Systems GmbH & Co. KG
Wilhelm Herbst Strasse 1
Bremen,  DE 28359
Applicant Contact MARTIN ELLERHORST
Correspondent
Bego Implant Systems GmbH & Co. KG
Wilhelm Herbst Strasse 1
Bremen,  DE 28359
Correspondent Contact MARTIN ELLERHORST
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/18/2009
Decision Date 10/06/2009
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
-
-