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
49–72 of 627
Cleared Dec 19, 2000
GOLD CORE HF PRE SOLDER
K002815
Jeneric/Pentron, Inc.
Dental · 99d
Cleared Nov 02, 2000
R&D PROJECT DW271#11A
K002872
Ivoclar North America, Inc.
Dental · 49d
Cleared Oct 19, 2000
JEL BIOS PURE
K002645
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Aug 31, 2000
RD-2104
K002222
J.F. Jelenko & Co., Inc.
Dental · 38d
Cleared May 17, 2000
ALLROUND 55 LF
K001260
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared May 11, 2000
JEL BIOS 90 (CODE NAME RD-2401)
K001196
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared Apr 28, 2000
RX EVEREST
K001051
Jeneric/Pentron, Inc.
Dental · 25d
Cleared Feb 18, 2000
RX G-UNIVERSAL
K000360
Jeneric/Pentron, Inc.
Dental · 14d
Cleared Dec 06, 1999
V-SUPRAGOLD, ALLOY NO. 5024
K993507
Metalor Dental USA Corp.
Dental · 52d
Cleared Dec 06, 1999
V-SUPRA PLUS, ALLOY NO. 5025
K993508
Metalor Dental USA Corp.
Dental · 52d
Cleared Oct 26, 1999
GOLD CORE 55
K993173
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Oct 26, 1999
GOLD CORE 75
K993175
Jeneric/Pentron, Inc.
Dental · 34d
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 Jan 13, 1999
MAINBOND A
K984140
J.F. Jelenko & Co., Inc.
Dental · 56d
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 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 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