FDA 510(k) Applications for Medical Device Product Code "ELR"
(Post, Root Canal)

FDA 510(k) Number Applicant Device Name Decision Date
K974649 ADVANCED AEROMEDICAL, INC. BIO-POST DENTAL POST SYSTEM 05/01/1998
K000311 COLTENE/WHALEDENT INC. PARAPOST FIBER WHITE 03/14/2000
K993545 COLTENE/WHALEDENT INC. TENAX WHITE POST 04/14/2000
K012354 DANVILLE MATERIALS, INC. SNOWPOST, SNOWLIGHT 10/10/2001
K020431 EST. ANTHOGYR FIBIOCORE 07/03/2002
K060075 FOREMOST DENTAL LLC. FIBER-METAL POST 03/30/2006
K003219 HARALD NORDIN S.A HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST 10/25/2000
K003221 HARALD NORDIN S.A HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST 10/25/2000
K972875 IVOCLAR NORTH AMERICA, INC. COSMOPOST 09/17/1997
K013802 IVOCLAR VIVADENT, INC. FRC POSTEC 05/01/2002
K042848 IVOCLAR VIVADENT, INC. FRC POSTEC PLUS 11/22/2004
K012496 J. MORITA USA, INC. CARBON POST 05/17/2002
K012849 J. MORITA USA, INC. GLASS POST 03/27/2002
K983266 JENERIC/PENTRON, INC. FIBREKOR POST SYSTEM 11/09/1998
K983161 SABRE-K LTD. KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC 09/30/1998
K030820 STICK TECH LTD. EVERSTICK POST 05/20/2003


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