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510(k) K993545

Device
TENAX WHITE POST
Applicant
COLTENE/WHALEDENT INC.
510(k) number
K993545
Product code
ELR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-04-14
Date received
1999-10-19
Regulation
872.3810
Classification name
Post, Root Canal
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
H.J. VOGELSTEIN
Address
750 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060075FIBER-METAL POSTForemost Dental, LLC2006-03-30
K042848FRC POSTEC PLUSIvoclar Vivadent, Inc.2004-11-22
K030820EVERSTICK POSTStick Tech , Ltd.2003-05-20
K020431FIBIOCOREEst. Anthogyr2002-07-03
K012496CARBON POSTJ. Morita USA, Inc.2002-05-17
K013802FRC POSTECIvoclar Vivadent, Inc.2002-05-01
K012849GLASS POSTJ. Morita USA, Inc.2002-03-27
K012354SNOWPOST, SNOWLIGHTDanville Materials, Inc.2001-10-10
K003219HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POSTHarald Nordin S.A2000-10-25
K003221HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POSTHarald Nordin S.A2000-10-25
K000311PARAPOST FIBER WHITEColtene/Whaledent, Inc.2000-03-14
K983266FIBREKOR POST SYSTEMJeneric/Pentron, Inc.1998-11-09
K983161KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOCSabre-K , Ltd.1998-09-30
K974649BIO-POST DENTAL POST SYSTEMAdvanced Aeromedical, Inc.1998-05-01
K972875COSMOPOSTIvoclar North America, Inc.1997-09-17

Legacy Summary#

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FDA Review#

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