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 K122424
Device Name ISUS IMPLANT SUPRASTRUCTURES
Applicant
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St.
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St.
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/09/2012
Decision Date 07/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-