ELR · Class I · 21 CFR 872.3810

FDA Product Code ELR: Post, Root Canal

Leading manufacturers include Coltene/Whaledent, Inc., J. Morita USA, Inc. and Ivoclar Vivadent, Inc..

35
Total
35
Cleared
120d
Avg days
1980
Since

FDA 510(k) Cleared Post, Root Canal Devices (Product Code ELR)

35 devices
1–24 of 35
Cleared Mar 30, 2006
FIBER-METAL POST
K060075
Foremost Dental, LLC
Dental · 79d
Cleared Nov 22, 2004
FRC POSTEC PLUS
K042848
Ivoclar Vivadent, Inc.
Dental · 38d
Cleared May 17, 2002
CARBON POST
K012496
J. Morita USA, Inc.
Dental · 287d
Cleared May 01, 2002
FRC POSTEC
K013802
Ivoclar Vivadent, Inc.
Dental · 167d
Cleared Mar 27, 2002
GLASS POST
K012849
J. Morita USA, Inc.
Dental · 236d
Cleared Apr 14, 2000
TENAX WHITE POST
K993545
Coltene/Whaledent, Inc.
Dental · 178d
Cleared Mar 14, 2000
PARAPOST FIBER WHITE
K000311
Coltene/Whaledent, Inc.
Dental · 42d
Cleared Nov 09, 1998
FIBREKOR POST SYSTEM
K983266
Jeneric/Pentron, Inc.
Dental · 53d
Cleared Sep 30, 1998
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
K983161
Sabre-K , Ltd.
Dental · 21d
Cleared May 01, 1998
BIO-POST DENTAL POST SYSTEM
K974649
Advanced Aeromedical, Inc.
Dental · 140d
Cleared Sep 17, 1997
COSMOPOST
K972875
Ivoclar North America, Inc.
Dental · 44d
Cleared Mar 31, 1995
C-POST
K945370
Bisco, Inc.
Dental · 149d
Cleared Mar 23, 1995
THE STERN ROOT ANCHOR SYSTEM
K950213
Sterngold/Implamed
Dental · 63d
Cleared Jun 06, 1994
PARAPOST XT SYSTEM
K934192
Coltene/Whaledent, Inc.
Dental · 284d
Cleared Aug 20, 1991
ENDO-CORE
K912720
Metalor Dental USA Corp.
Dental · 63d
Cleared Mar 05, 1990
FILPOST
K896928
Ivoclar North America, Inc.
Dental · 84d
Cleared Feb 14, 1990
FLEXI-CAST CROWN CORE SYSTEM
K896693
Essential Dental Systems, Inc.
Dental · 78d
Cleared Dec 22, 1988
AD POST
K884277
J. Morita USA, Inc.
Dental · 71d
Cleared Aug 11, 1988
CENTRIX TRI-LAMINATE POST SYSTEM
K882125
Centrix, Inc.
Dental · 83d
Cleared Feb 19, 1987
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
K870130
Den-Mat Corp.
Dental · 38d
Cleared Nov 12, 1980
ROOT CANAL POST
K802515
Unitek Corp.
Dental · 28d

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