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
121–144 of 627
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 13, 1996
JEL-40 (CODE NAME RD-0430)
K964158
Jelenko Co.
Dental · 58d
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
Cleared Nov 20, 1996
PALLADIA 75 (PM-11)
K964466
Gateway Alloys, Inc.
Dental · 13d
Cleared Jul 24, 1996
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
K962325
Sterngold/Implamed
Dental · 37d
Cleared Jul 24, 1996
STERNGOLD BIO-5 (1127210)
K962326
Sterngold/Implamed
Dental · 37d
Cleared Jul 18, 1996
PEGASUS DENTAL ALLOY
K962302
Sterngold/Implamed
Dental · 31d
Cleared Jul 18, 1996
STERNGOLD CF
K962303
Sterngold/Implamed
Dental · 31d
Cleared May 29, 1996
STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200
K960956
Sterngold/Implamed
Dental · 79d