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 K160798
Device Name IPS e.max® Press Abutment Solutions for Viteo Base Ti
Applicant
IVOCLAR VIVADENT AG
BENDERERSTRASSE 2
SCHAAN,  LI FL-9494
Applicant Contact Sandra Cakebread
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/23/2016
Decision Date 12/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-