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
265–288 of 627
Cleared Apr 29, 1991
AUROFLUID 3
K911539
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
PROTH-AURO 22
K911540
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
PONTOR 4 CF
K911541
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
PONTOR 2
K911542
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
SOLARO 3
K911543
Metalor Dental USA Corp.
Dental · 28d
Cleared Apr 29, 1991
SOLARO 4
K911544
Metalor Dental USA Corp.
Dental · 28d
Cleared Mar 15, 1991
GDC-3200 DENTAL SOLDER
K910065
Deringer-Ney, Inc.
Dental · 65d
Cleared Feb 26, 1991
WLW
K905320
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
MAXIGOLD
K905327
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
WILL-CERAM W
K905329
Ivoclar North America, Inc.
Dental · 90d
Cleared Jan 29, 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761
Argen Precious Metals, Inc.
Dental · 33d
Cleared Jan 29, 1991
ARGENCO 52HN
K905811
Argen Precious Metals, Inc.
Dental · 32d
Cleared Jan 16, 1991
MIDIGOLD 50
K905322
Ivoclar North America, Inc.
Dental · 49d
Cleared Jan 15, 1991
VARIOUS
K905319
Ivoclar North America, Inc.
Dental · 48d
Cleared Jan 15, 1991
DEGUDENT GS
K905387
Degussa AG
Dental · 46d
Cleared Jan 02, 1991
GDC-1501
K904695
Deringer-Ney, Inc.
Dental · 78d
Cleared Dec 27, 1990
THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
K905197
Ormco Corp.
Dental · 37d
Cleared Dec 24, 1990
WILL-CERAM Y AND WILL -CERAM Y-1
K905323
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
WILL-CERAM W-1
K905324
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
MINIGOLD
K905326
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
HARMONY LINE ALLOYS
K905330
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 21, 1990
X-L AND X-LX
K905325
Ivoclar North America, Inc.
Dental · 23d
Cleared Dec 19, 1990
GDC-1475
K904614
Deringer-Ney, Inc.
Dental · 69d
Cleared Nov 01, 1990
ARGENCO 19
K904437
Argen Precious Metals, Inc.
Dental · 34d