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 Abutment, Implant, Dental, Endosseous
510(k) Number K122559
Device Name BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
Applicant
BIODENTA SWISS AG
TRAMSTRASSE 16
BERNECK,  CH 9442
Applicant Contact DAVID EILER
Correspondent
BIODENTA SWISS AG
TRAMSTRASSE 16
BERNECK,  CH 9442
Correspondent Contact DAVID EILER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/22/2012
Decision Date 05/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-