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
97–120 of 627
Cleared Sep 05, 1997
PALAUREX 78
K972954
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 56
K972955
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 82SF
K972956
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Aug 28, 1997
AURECAST 74
K972941
Aurex Precious Metal Industries (Pty)Ltd
Dental · 69d
Cleared Aug 28, 1997
AURECAST 83
K972942
Aurex Precious Metal Industries (Pty)Ltd
Dental · 69d
Cleared Aug 26, 1997
AURECAST GF
K972319
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
AURECAST BIO 59PF
K972939
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
AURECAST BIO 69PF
K972940
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 25, 1997
AURECAST 2
K972936
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 4
K972937
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 25, 1997
AURECAST 10
K972938
Aurex Precious Metal Industries (Pty)Ltd
Dental · 66d
Cleared Aug 15, 1997
AALBA GOLD SOLDER
K972532
Aalba Dent, Inc.
Dental · 39d
Cleared Aug 15, 1997
VERA PD SOLDER
K972632
Aalba Dent, Inc.
Dental · 32d
Cleared Jun 04, 1997
BENCHMARK-IV
K971575
J.F. Jelenko & Co., Inc.
Dental · 58d
Cleared May 20, 1997
JEL-71 PDF
K971292
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 20, 1997
JELBOND-PDF
K971574
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared Apr 30, 1997
TARGIS ALLOY #7
K970963
Ivoclar North America, Inc.
Dental · 44d
Cleared Mar 24, 1997
JELENKO NO.1 (CODE NAME RD-0601)
K970068
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Jan 17, 1997
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)
K964772
Ivoclar North America, Inc.
Dental · 51d
Cleared Jan 13, 1997
TAOS 28
K964940
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
EL DORADO 40
K964941
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 52 (PM-01)
K964948
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 53
K964949
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
LA PLATA 28 (PM-28)
K964950
Gateway Alloys, Inc.
Dental · 34d