EJT · Class II · 21 CFR 872.3060

FDA Product Code EJT: Alloy, Gold-based Noble Metal

Leading manufacturers include Argen Precious Metals, Inc., J.F. Jelenko & Co., Inc. and Metalor Dental USA Corp..

627
Total
627
Cleared
57d
Avg days
1976
Since
627 devices
145–168 of 627
Cleared May 20, 1996
285 SL
K961352
Argen Precious Metals, Inc.
Dental · 42d
Cleared Apr 25, 1996
ARGELITE 52+
K961211
Argen Precious Metals, Inc.
Dental · 28d
Cleared Apr 18, 1996
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K961285
Argen Precious Metals, Inc.
Dental · 15d
Cleared Feb 26, 1996
DIAMOND (CODE NAME PT-054)
K960403
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared Feb 21, 1996
DEGUDENT LS
K960256
Degussa Corp.
Dental · 34d
Cleared Feb 21, 1996
TOPAZ
K960399
J.F. Jelenko & Co., Inc.
Dental · 23d
Cleared Feb 14, 1996
DG 88
K960226
Degussa Corp.
Dental · 28d
Cleared Feb 06, 1996
BIOCCLUS 4
K960104
Degussa Corp.
Radiology · 26d
Cleared Dec 11, 1995
DEGUBOND X-LITE PLUS
K955118
Degussa Corp.
Dental · 32d
Cleared Dec 01, 1995
DEGUBOND X-LITE
K955027
Degussa Corp.
Dental · 29d
Cleared Nov 15, 1995
DW260 19
K954837
Ivoclar North America, Inc.
Dental · 26d
Cleared Oct 30, 1995
IMPLANTALOY
K954702
Metalor Dental USA Corp.
Dental · 18d
Cleared Oct 12, 1995
ARGISTAR 74
K954362
Argen Precious Metals, Inc.
Dental · 24d
Cleared Oct 07, 1995
ARGENDENT GIO 86 FR
K954358
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
SILFREE 80SF+
K954359
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
ARGESOL 600
K954360
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
ARGENCO 68M
K954361
Argen Precious Metals, Inc.
Dental · 19d
Cleared Oct 07, 1995
ARGISTAR BIO 75PF
K954367
Argen Precious Metals, Inc.
Dental · 22d
Cleared Oct 07, 1995
ARGEDENT BIO 87 PF
K954368
Argen Precious Metals, Inc.
Dental · 22d
Cleared Oct 07, 1995
SUREFIRE S
K954371
Argen Precious Metals, Inc.
Dental · 18d
Cleared Oct 07, 1995
AUROLITE 45
K954404
Argen Precious Metals, Inc.
Dental · 17d
Cleared Aug 25, 1995
DEGUBOND ULTRA
K953344
Degussa AG
Dental · 44d
Cleared Jun 22, 1995
VS11 SF
K951271
Metalor Dental USA Corp.
Dental · 93d
Cleared Jun 21, 1995
AUROLITE 80
K952403
Argen Precious Metals, Inc.
Dental · 30d