EJJ · Class II · 21 CFR 872.3070

FDA Product Code EJJ: Alloy, Amalgam

Leading manufacturers include Southern Dental Industries, Inc., Ab Ardent and Ivoclar North America, Inc..

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 Nov 15, 2005

Dunia Perwira Manufacturing Sdn. Bhd.

Cleared May 02, 2005

SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

Cleared Aug 06, 2003

Southern Dental Industries, Inc.

Cleared Jul 29, 2003

BENCO SPHERICAL

Southern Dental Industries, Inc.

Cleared May 07, 2002

HIGH SILVER CONVENTIONAL

Cleared Aug 16, 2001

FUTURA TOPCAP NON GAMMA-2

Cleared Oct 31, 2000

ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

Nordiska Dental AB

Cleared Oct 31, 2000

ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY

Nordiska Dental AB

Cleared Oct 31, 2000

ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY

Nordiska Dental AB

Cleared Aug 11, 1999

Lancer Orthodontics, Inc.

Cleared Oct 19, 1998

Specialites Septodont

Cleared Aug 24, 1998

Cleared Aug 24, 1998

Cleared Aug 24, 1998

Cleared Dec 17, 1997

Cleared Oct 07, 1997

Southern Dental Industries, Inc.

Cleared Oct 03, 1997

Southern Dental Industries, Inc.

Cleared Jan 06, 1997

ARDENT NON GAMMA-2 70

Ardent Production Development

Cleared Dec 10, 1996

ARDENT FUTURA NON GAMMA-2

Ardent Production Development

Cleared Jan 24, 1996

Southern Dental Industries, Inc.

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)

About Product Code EJJ - Regulatory Context

Related FDA 510(k) Regulatory Insights