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 K211109
Device Name N1 TiUltra TCC Implant System
Applicant
Nobel Biocare Services AG
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare Services AG
Balz Zimmermann-Str. 7
Kloten,  CH 8302
Correspondent Contact Bernice Jim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Codes
NHA   PNP   QRQ  
Date Received04/14/2021
Decision Date 12/21/2021
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
Recalls CDRH Recalls
-
-