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
25–48 of 627
Cleared Sep 12, 2002
PORTA OP SOLDER W-2
K022454
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
AUROPAL SOLDER M-1
K022459
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 11, 2002
AUROPAL SOLDER W-2
K022451
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
PORTA OP SOLDER M-1
K022452
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Jul 25, 2002
BRIGHT GOLD
K021892
Ivoclar Vivadent, Inc.
Dental · 48d
Cleared Jul 25, 2002
AUROPAL 60
K021926
Wieland Dental + Technik GmbH & Co. KG
Dental · 43d
Cleared Jun 26, 2002
AUTOPAL 50
K021733
Wieland Dental + Technik GmbH & Co. KG
Dental · 29d
Cleared May 16, 2002
PORTALLOY 54
K021242
Wieland Dental + Technik GmbH & Co. KG
Dental · 27d
Cleared Mar 13, 2002
PORTADUR P 4
K020190
Wieland Dental + Technik GmbH & Co. KG
Dental · 50d
Cleared Aug 27, 2001
GPW-SF
K011659
Gateway Alloys, Inc.
Dental · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661
Gateway Alloys, Inc.
Dental · 90d
Cleared Jul 16, 2001
CONCORD 72
K011626
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
CONCORD 82
K011628
Gateway Alloys, Inc.
Dental · 48d
Cleared Jun 22, 2001
JP CAST 50
K011330
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
JP CAST 40
K011331
Jeneric/Pentron, Inc.
Dental · 51d
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 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