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 K091182
Device Name CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
Applicant
Champions Implants GmbH
Jahnstrasse 14
Tuningen, Baden-Wuerttemberg,  DE 78609
Applicant Contact MARCUS WEINACKER
Correspondent
Champions Implants GmbH
Jahnstrasse 14
Tuningen, Baden-Wuerttemberg,  DE 78609
Correspondent Contact MARCUS WEINACKER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/23/2009
Decision Date 01/07/2010
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
-
-