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

FDA 510(k) Cleared Alloy, Gold-based Noble Metal Devices (Product Code EJT)

627 devices
1–24 of 627
Cleared Oct 14, 2005
PROMETAL HN86
K052463
Prometal Technologies
Dental · 36d
Cleared Aug 02, 2004
BIO 60
K041378
Kodent, Inc.
Dental · 70d
Cleared May 27, 2004
PORTA REFLEX
K040672
Wieland Dental + Technik GmbH & Co. KG
Dental · 73d
Cleared May 20, 2004
PORTA SOLDER 1090 W
K040524
Wieland Dental + Technik GmbH & Co. KG
Dental · 80d
Cleared Mar 03, 2004
NDX-40 ALLOY
K040043
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Oct 01, 2003
APPOLLO 3 ALLOY
K032320
Dentsply International
Dental · 65d
Cleared Sep 30, 2003
ORION E ALLOY
K032316
Dentsply Intl.
Dental · 64d
Cleared Sep 30, 2003
ORION GX ALLOY
K032317
Dentsply Intl.
Dental · 64d
Cleared Sep 30, 2003
MINERVA 58 ALLOY
K032318
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA R PLUS ALLOY
K032319
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA F ALLOY
K032321
Dentsply International
Dental · 64d
Cleared Sep 26, 2003
DW 296 #15 SOLDER
K032715
Ivoclar Vivadent, Inc.
Dental · 24d
Cleared Sep 26, 2003
ULTRACROWN 75 ALLOY
K032851
Dentsply International
Dental · 14d
Cleared Sep 17, 2003
R&D DESIGNATION AP-052-5
K032267
Jensen Industries, Inc.
Dental · 56d
Cleared Sep 04, 2003
ALEXANDER
K032493
Ivoclar Vivadent, Inc.
Dental · 23d
Cleared Jun 12, 2003
PORTA PRESSOVER
K031264
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Apr 15, 2003
BIOUNIVERSAL PKF
K030435
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 15, 2003
BIO UNIVERSAL
K030436
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Mar 26, 2003
PORTA IMPLANT
K030312
Wieland Dental + Technik GmbH & Co. KG
Dental · 55d
Cleared Dec 11, 2002
PORTADUR P2
K023395
Wieland Dental + Technik GmbH & Co. KG
Dental · 63d
Cleared Dec 10, 2002
BIOPORTA G
K023391
Wieland Dental + Technik GmbH & Co. KG
Dental · 62d
Cleared Dec 06, 2002
PORTA GEO TI
K023389
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Dec 06, 2002
AGC SPECIAL ALLOY
K023392
Wieland Dental + Technik GmbH & Co. KG
Dental · 58d
Cleared Oct 31, 2002
KERADEC
K022663
Wieland Dental + Technik GmbH & Co. KG
Dental · 83d

About Product Code EJT - Regulatory Context