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 K033922
Device Name MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
Applicant
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Applicant Contact CAROLYN BITETTI
Correspondent
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Correspondent Contact CAROLYN BITETTI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/18/2003
Decision Date 01/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-