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 Agent, Tooth Bonding, Resin
510(k) Number K052189
Device Name REVENEER CERAMIC REPAIR SYSTEM
Applicant
Schutz-Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE D-61191
Applicant Contact MICHAEL WIERZ
Correspondent
Schutz-Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE D-61191
Correspondent Contact MICHAEL WIERZ
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/11/2005
Decision Date 10/17/2005
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
-
-