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 Coating, Filling Material, Resin
510(k) Number K211854
Device Name VITA Akzent LC
Applicant
Vita Zahnfabrik GmbH H Rauter & CO
Spitelgasse 3
Bad Sackingen,  DE D-79713
Applicant Contact Bernd Walker
Correspondent
Vita North America
22705 Savi Ranch Pkwy., Suite 100
Yorba Linda,  CA  92887
Correspondent Contact Lindsay Tilton
Regulation Number872.3310
Classification Product Code
EBD  
Date Received06/16/2021
Decision Date 11/22/2021
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
-
-