EJJ · Class II · 21 CFR 872.3070

FDA Product Code EJJ: Alloy, Amalgam

Leading manufacturers include Ivoclar North America, Inc., Jeneric/Pentron, Inc. and Degussa AG.

74

Total

74

Cleared

63d

Avg days

1976

Since

FDA 510(k) Cleared Alloy, Amalgam Devices (Product Code EJJ)

74 devices

1–24 of 74

Cleared Dec 17, 1997

Cleared Jun 06, 1995

Kerr Corporation (Danbury)

Cleared May 02, 1995

Kerr Corporation (Danbury)

Cleared Apr 29, 1994

Sybron Dental Specialties, Inc.

Cleared Mar 11, 1994

Kerr Corporation (Danbury)

Cleared Mar 29, 1991

Ivoclar North America, Inc.

Cleared Dec 17, 1990

Ivoclar North America, Inc.

Cleared Jul 13, 1990

ARTALLOY (POWDER)

Cleared Jul 13, 1990

LUXALLOY CAPS (PREDOSED CAPSULES)

Cleared Jul 13, 1990

LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)

Cleared Jun 01, 1990

VIVAALLOY HR (AMALGAM)

Ivoclar North America, Inc.

Cleared Apr 27, 1990

Ivoclar North America, Inc.

Cleared May 09, 1989

Jeneric/Pentron, Inc.

Cleared May 05, 1989

Jeneric/Pentron, Inc.

Cleared May 02, 1989

Jeneric/Pentron, Inc.

Cleared Apr 21, 1988

J.F. Jelenko & Co., Inc.

Cleared Mar 18, 1988

HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY

Cleared May 20, 1987

ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2

Degussa Dental, Inc.

Cleared Oct 26, 1982

Cleared Jul 20, 1982

VALULINE* AMALGAM ALLOY

Johnson & Johnson Professionals, Inc.

Cleared Mar 11, 1982

A DENTAL AMALGAM ALLOY (UNNAMED

Cleared Feb 24, 1982

SYBRON/KERR CONTOUR

Cleared Nov 16, 1981

ORBIC* SPHERICAL ALLOY

Johnson & Johnson Professionals, Inc.

Cleared Aug 21, 1978

ALLOY, AMALGAM, DISP. CAPSULE

Lee Pharmaceuticals

About Product Code EJJ - Regulatory Context

Related FDA 510(k) Regulatory Insights