ELR · Class I · 21 CFR 872.3810

FDA Product Code ELR: Post, Root Canal

Leading manufacturers include J. Morita USA, Inc., Ivoclar Vivadent, Inc. and Ivoclar North America, 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 Nov 22, 2004

FRC POSTEC PLUS

Ivoclar Vivadent, Inc.

Cleared May 17, 2002

J. Morita USA, Inc.

Cleared May 01, 2002

Ivoclar Vivadent, Inc.

Cleared Mar 27, 2002

J. Morita USA, Inc.

Cleared Nov 09, 1998

FIBREKOR POST SYSTEM

Jeneric/Pentron, Inc.

Cleared Sep 17, 1997

Ivoclar North America, Inc.

Cleared Mar 31, 1995

Cleared Aug 20, 1991

Metalor Dental USA Corp.

Cleared Mar 05, 1990

Ivoclar North America, Inc.

Cleared Dec 22, 1988

J. Morita USA, Inc.

Cleared Aug 11, 1988

CENTRIX TRI-LAMINATE POST SYSTEM

About Product Code ELR - Regulatory Context

Related FDA 510(k) Regulatory Insights