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
73–96 of 627
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
Cleared Dec 20, 1996
EL DORADO 55
K964788
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
LA PLATA 39
K964789
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
LA PLATA 40
K964792
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
PACIFIC 56 (CB-40)
K964837
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 20, 1996
PALLADIA 85 (PM-13)
K964838
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 16, 1996
SOLDER 615
K964708
Gateway Alloys, Inc.
Dental · 21d
Cleared Dec 06, 1996
OZARK 20
K964566
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
EL DORADO 75
K964567
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
OZARK 46
K964568
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
EL DORADO 58
K964569
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
PALLADIA 76
K964572
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
PIEDMONT 70 (CH-35)
K964573
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 04, 1996
DE ORO 77
K964476
Gateway Alloys, Inc.
Dental · 27d
Cleared Dec 02, 1996
OZARK 40
K964477
Gateway Alloys, Inc.
Dental · 25d
Cleared Nov 26, 1996
PACIFIC 52 (CB-39)
K964464
Gateway Alloys, Inc.
Dental · 19d
Cleared Nov 26, 1996
LA PLATA 34 (PM-25)
K964465
Gateway Alloys, Inc.
Dental · 19d
Cleared Nov 26, 1996
OSAGE 76
K964478
Gateway Alloys, Inc.
Dental · 19d