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 May 29, 2001
GOLD CORE 73 LS
K011362
Jeneric/Pentron, Inc.
Dental · 26d
Cleared May 10, 2001
RD-3008
K011036
Heraeus Kulzer, Inc.
Dental · 35d
Cleared May 02, 2001
BIOUNIVERSAL PDF
K011022
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
D.SIGN 96
K011023
Ivoclar North America, Inc.
Dental · 28d
Cleared Mar 27, 2001
R & D DESIGNATION AP-035
K010414
Jensen Industries, Inc.
Dental · 43d
Cleared Mar 27, 2001
R & D DESIGNATION AP-047
K010611
Jensen Industries, Inc.
Dental · 26d
Cleared Feb 09, 2001
COSMIC
K010044
Jeneric/Pentron, Inc.
Dental · 35d
Cleared Dec 22, 2000
DW 276 #3
K003635
Ivoclar North America, Inc.
Dental · 28d
Cleared Dec 21, 2000
DW 272 #1
K003634
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 20, 2000
GOLD CORE POST SOLDER
K002854
Jeneric/Pentron, Inc.
Dental · 100d
Cleared Dec 20, 2000
DW 277 #4
K003633
Ivoclar North America, Inc.
Dental · 26d
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 24, 2000
EQUITY
K002826
Jensen Industries, Inc.
Dental · 43d
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