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
74 devices
25–48 of 74
Cleared Dec 27, 1991
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175
G-C Intl. Corp.
Dental · 163d
Cleared Mar 29, 1991
DW 236
K905204
Ivoclar North America, Inc.
Dental · 129d
Cleared Dec 17, 1990
DW 235
K905205
Ivoclar North America, Inc.
Dental · 27d
Cleared Jul 13, 1990
ARTALLOY (POWDER)
K902247
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY CAPS (PREDOSED CAPSULES)
K902248
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)
K902249
Degussa AG
Dental · 56d
Cleared Jun 01, 1990
VIVAALLOY HR (AMALGAM)
K901911
Ivoclar North America, Inc.
Dental · 36d
Cleared Apr 27, 1990
AMALCAP PLUS
K901256
Ivoclar North America, Inc.
Dental · 43d
Cleared May 09, 1989
PENT CAPS
K890662
Jeneric/Pentron, Inc.
Dental · 89d
Cleared May 05, 1989
OROSPHERE PLUS
K890682
Jeneric/Pentron, Inc.
Dental · 85d
Cleared May 02, 1989
OROSPHERE HCDP
K890681
Jeneric/Pentron, Inc.
Dental · 82d
Cleared Apr 21, 1988
OLYMPIA ALLOY
K881333
J.F. Jelenko & Co., Inc.
Dental · 23d
Cleared Mar 18, 1988
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344
Kulzer, Inc.
Dental · 79d
Cleared May 20, 1987
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
K870230
Degussa Dental, Inc.
Dental · 119d
Cleared Mar 25, 1985
LIMI ALLOY
K844653
G-C Intl. Corp.
Dental · 116d
Cleared Oct 26, 1982
SPHEREX E.C.T.
K822951
Jeneric Ind.
Dental · 22d
Cleared Jul 20, 1982
VALULINE* AMALGAM ALLOY
K821971
Johnson & Johnson Professionals, Inc.
Dental · 14d
Cleared Mar 11, 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389
Dentsply Intl.
Dental · 29d
Cleared Feb 24, 1982
SYBRON/KERR CONTOUR
K820181
Sybron Corp.
Dental · 33d
Cleared Nov 16, 1981
ORBIC* SPHERICAL ALLOY
K812827
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Aug 27, 1980
PERMITE DENTAL AMALGAM ALLOY
K801639
Southern Dental Industries, Inc.
Dental · 41d
Cleared Aug 13, 1980
VALIANT
K801690
L.D. Caulk Co.
Dental · 21d
Cleared Jun 05, 1979
AMALCAP-NON-GAMMA-2
K790874
Vivadent (Usa), Inc.
Dental · 29d
Cleared Aug 21, 1978
ALLOY, AMALGAM, DISP. CAPSULE
K781242
Lee Pharmaceuticals
Dental · 70d