ELR · Class I · 21 CFR 872.3810

FDA Product Code ELR: Post, Root Canal

Leading manufacturers include Coltene/Whaledent, Inc., Harald Nordin S.A and J. Morita USA, 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

Foremost Dental, LLC

Cleared Nov 22, 2004

FRC POSTEC PLUS

Ivoclar Vivadent, Inc.

Cleared May 20, 2003

Stick Tech , Ltd.

Cleared Jul 03, 2002

Cleared May 17, 2002

J. Morita USA, Inc.

Cleared May 01, 2002

Ivoclar Vivadent, Inc.

Cleared Mar 27, 2002

J. Morita USA, Inc.

Cleared Oct 10, 2001

SNOWPOST, SNOWLIGHT

Danville Materials, Inc.

Cleared Oct 25, 2000

HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

Harald Nordin S.A

Cleared Oct 25, 2000

HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST

Harald Nordin S.A

Cleared Apr 14, 2000

TENAX WHITE POST

Coltene/Whaledent, Inc.

Cleared Mar 14, 2000

PARAPOST FIBER WHITE

Coltene/Whaledent, Inc.

Cleared Nov 09, 1998

FIBREKOR POST SYSTEM

Jeneric/Pentron, Inc.

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

Cleared May 01, 1998

BIO-POST DENTAL POST SYSTEM

Advanced Aeromedical, Inc.

Cleared Sep 17, 1997

Ivoclar North America, Inc.

Cleared Mar 31, 1995

Cleared Mar 23, 1995

THE STERN ROOT ANCHOR SYSTEM

Sterngold/Implamed

Cleared Aug 05, 1994

Dental Logics, Inc.

Cleared Jul 08, 1994

CONSERVA POST SYSTEM

Bull Frog Mfg. Co.

Cleared Jun 06, 1994

PARAPOST XT SYSTEM

Coltene/Whaledent, Inc.

Cleared May 26, 1994

THERMAPOST ENDODONTIC ROOT CANAL POST

Tulsa Dental Products, Ltd.

Cleared Apr 28, 1994

DENTAL SCREW POSTS

Harald Nordin S.A

Cleared Mar 15, 1994

VERSADOWEL POST SYSTEM

Dental Power, Inc.

About Product Code ELR - Regulatory Context

Related FDA 510(k) Regulatory Insights