EJS · Class II · 21 CFR 872.3060

FDA Product Code EJS: Alloy, Other Noble Metal

Leading manufacturers include Metalor Dental USA Corp., Deringer-Ney, Inc. and Ivoclar North America, Inc..

194
Total
194
Cleared
59d
Avg days
1976
Since
194 devices
49–72 of 194
Cleared May 05, 1993
NUGOLD 2%
K926145
Jeneric/Pentron, Inc.
Dental · 149d
Cleared Mar 01, 1993
CERAPALL 6 -- MODIFIED
K924292
Metalor Dental USA Corp.
Dental · 245d
Cleared Feb 26, 1993
KB58-KF
K922958
Jeneric/Pentron, Inc.
Dental · 253d
Cleared Dec 23, 1992
ZENON PLUS
K922955
Jeneric/Pentron, Inc.
Dental · 188d
Cleared Dec 21, 1992
GDC 3445
K925273
Deringer-Ney, Inc.
Dental · 63d
Cleared Sep 14, 1992
KB40-KF
K922956
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Sep 14, 1992
PARAGON
K922957
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Aug 05, 1992
ACCU-STAR
K922446
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK III
K922447
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK I
K922448
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
PA-400
K922449
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
BENCHMARK C
K922450
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Aug 05, 1992
LEGACY-XT
K922451
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared May 26, 1992
DEVA PLUS
K921419
Degussa AG
Dental · 63d
Cleared May 26, 1992
DEGUBOND PLUS
K921445
Degussa AG
Dental · 62d
Cleared May 05, 1992
GDC 3367
K920922
Deringer-Ney, Inc.
Dental · 67d
Cleared Apr 21, 1992
ARGEBOND 77+
K915165
Argen Precious Metals, Inc.
Dental · 158d
Cleared Apr 21, 1992
DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
K920613
Ivoclar North America, Inc.
Dental · 70d
Cleared Mar 19, 1992
GDC-3338, DENTAL SOLDER ALLOY
K920887
Deringer-Ney, Inc.
Dental · 77d
Cleared Nov 13, 1991
ARGEBOND 80
K913704
Argen Precious Metals, Inc.
Dental · 86d
Cleared Nov 13, 1991
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860
Dentsply Intl.
Dental · 78d
Cleared Nov 13, 1991
PLATINUM FOIL PLATINUM MILING WAFER
K914627
Metalor Dental USA Corp.
Dental · 28d
Cleared Oct 02, 1991
DW238 #228-34A
K913068
Ivoclar North America, Inc.
Dental · 83d
Cleared Oct 02, 1991
DW238 #228-04B
K913069
Ivoclar North America, Inc.
Dental · 83d