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 Oct 21, 1999
JEL BIOS 10 (CODE NAME RD-1801)
K993136
J.F. Jelenko & Co., Inc.
Dental · 31d
Cleared Oct 21, 1999
JEL BIOS 18 (CODE NAME RD- 1214)
K993152
J.F. Jelenko & Co., Inc.
Dental · 30d
Cleared Sep 07, 1999
BIO-97
K991901
Jeneric/Pentron, Inc.
Dental · 95d
Cleared Apr 02, 1999
HELIOFORM GOLD-BASED ALLOY
K990670
C. Hafner GmbH & Co.
Dental · 31d
Cleared Jan 13, 1999
MAINBOND A
K984140
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Oct 28, 1998
AUROLLOYD KF
K983080
Bego U.S.A.
Dental · 56d
Cleared Oct 28, 1998
BEGOCER G
K983082
Bego U.S.A.
Dental · 56d
Cleared Oct 23, 1998
BIO PONTOSTAR
K983077
Bego U.S.A.
Dental · 51d
Cleared Oct 23, 1998
PLATINLLOYD 100
K983079
Bego U.S.A.
Dental · 51d
Cleared Oct 15, 1998
AUROFLUID CPF
K982606
Metalor Dental USA Corp.
Dental · 80d
Cleared Aug 13, 1998
BW-1 (CODE NAME RD-0807)
K981244
J.F. Jelenko & Co., Inc.
Dental · 129d
Cleared Apr 27, 1998
BIOGOLD PLUS DENTAL ALLOY
K980660
European Dental Imports, Inc.
Dental · 66d
Cleared Mar 09, 1998
CARRARA PDF, CARRARA H, CARRARA R
K980597
European Dental Imports, Inc.
Dental · 20d
Cleared Mar 09, 1998
PROGOLD ELECTROCOPING SYSTEM
K980613
Micro Dental Laboratories
Dental · 19d
Cleared Dec 19, 1997
AURELUX 77
K972946
Aurex Precious Metal Industries (Pty)Ltd
Dental · 182d
Cleared Nov 26, 1997
AUROFILM 2000
K973372
Metalor Dental USA Corp.
Dental · 79d
Cleared Nov 24, 1997
PROSPECTOR PLUS (CODE NAME : RD-0508)
K973881
J.F. Jelenko & Co., Inc.
Dental · 41d
Cleared Oct 14, 1997
PORS ON LITE
K972910
Degussa Corp.
Dental · 68d
Cleared Sep 18, 1997
AURELUX BIO Y85PF
K972949
Aurex Precious Metal Industries (Pty)Ltd
Dental · 90d
Cleared Sep 16, 1997
AURECAST 92
K972943
Aurex Precious Metal Industries (Pty)Ltd
Dental · 88d
Cleared Sep 05, 1997
HIPALLAUR 19
K972950
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
HIPALLAUR 51
K972951
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
AUREBOND 51
K972952
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALAUREX 76KF
K972953
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d