• 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 crown and bridge, temporary, resin
510(k) Number K071548
Device Name WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
Applicant
MERZ DENTAL GMBH
5616 MARIOLA PL NE
ALBUQUERQUE,  NM  87111
Applicant Contact RICHARD G HUNTER
Correspondent
MERZ DENTAL GMBH
5616 MARIOLA PL NE
ALBUQUERQUE,  NM  87111
Correspondent Contact RICHARD G HUNTER
Regulation Number872.3770
Classification Product Code
EBG  
Date Received06/06/2007
Decision Date 08/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-