Product Code: EJS FDA class 2 21 CFR 872.3060

Alloy, Other Noble Metal

Dental

Other Noble Metal Alloy is a dental casting material composed of precious metals other than gold, such as palladium, platinum, or silver-based alloys, used to fabricate crowns, bridges, and other fixed prostheses offering corrosion resistance and biocompatibility. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EJS, regulated under 21 CFR 872.3060 in the Dental (DE) specialty.

510(k)s
194
FEI Numbers
47
Registration Numbers
47
Unique Applicants
45
Years Active
28

Basic Information

Product Code
EJS
Device Class
FDA class 2
Regulation Number
872.3060
Medical Specialty
Dental
Review Panel
DE
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 194 510(k) clearances via K numbers.

K Number Device Name
K041433 BRIGHT GOLD XH
K040436 SIMIDUR SUPERIOR
K022252 STERNGOLD 1, MODEL 1127781
K022469 ECO E4
K021367 STERNGOLD 66, MODEL #1180230
K020195 SIMIDUR S1S
K020194 SIMIDUR KF PLUS
K020192 SIMIDUR S2
K014042 D.SIGN 84
K013809 D.SIGN 59
K014082 D.SIGN 53, MODEL NA1012204
K012841 DUO PAL 6, ORDER-NO.: 2154
K012828 PORTA SMK 82, MODEL 2032
K012840 EURO 45, ORDER-NO.: 2064
K012303 JEL-20
K003632 DW 273 #1
K001469 R&D PROJECT DW269#25
K000532 JEL 15
K993475 AUROFLUID M, ALLOY NO. 5315
K993506 PAGALINOR 4 , ALLOY NO. 5440
K993505 V-DELTA SPECIAL, ALLOY NO. 5154
K993474 DELTAPAL, ALLOY NO. 5161
K984587 ALLROUND-E (CODE NAME RD 1710)
K990078 D-SIGN IV (R&D PROJECT DW265#37)
K990077 D-SIGN III (R&D PROJECT DW264#7)
K984451 D-SIGN I (R&D PROJECT DW263 #24)
K983081 BEGOPAL 300
K983078 BEGOPAL
K981257 JELFINE-52 (CODE NAME RD-0901)
K981247 SILCAST (CODE NAME RD-0118)
K981002 ORION WX DENTAL ALLOY
K981001 ORION VESTA DENTAL ALLOY
K980661 CERA E DENTAL ALLOY
K972945 AURENORM 68
K973288 STABILOR HN
K972534 ALFALLOY
K972533 VERA SOLDER
K972683 V-DELTA 450
K970045 SOLARO 33
K970044 AUROFLUID 22
K964713 SOLDER GPW
K964707 SOLDER 585
K964706 SOLDER 650
K964705 SOLDER GPY
K962324 STERNGOLD U-CPF METAL ALLOY (1067800)
K962304 STERNGOLD BIO-4
K962301 STERNGOLD G-HARD METAL ALLOY
K941625 DW234 #29
K934757 CU-FREE & LTA
K935388 CERAPALL 4CF
K934773 ARGELITE A
K933563 VS 1A
K926147 GOLD-PLATINUM BASED CASTING ALLOY
K926146 BIO C & B
K925331 CORRECT AND CORRECT FIT II
K926145 NUGOLD 2%
K924292 CERAPALL 6 -- MODIFIED
K922958 KB58-KF
K922955 ZENON PLUS
K925273 GDC 3445
K923644 DW243-64
K922957 PARAGON
K922956 KB40-KF
K922451 LEGACY-XT
K922450 BENCHMARK C
K922449 PA-400
K922448 BENCHMARK I
K922447 BENCHMARK III
K922446 ACCU-STAR
K921445 DEGUBOND PLUS
K921419 DEVA PLUS
K920922 GDC 3367
K920613 DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
K915165 ARGEBOND 77+
K920887 GDC-3338, DENTAL SOLDER ALLOY
K920560 DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL
K914627 PLATINUM FOIL PLATINUM MILING WAFER
K913860 ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913704 ARGEBOND 80
K913069 DW238 #228-04B
K913068 DW238 #228-34A
K913070 X-L (DW228-14A) AND X-LX (DW228-24A)
K913232 ULTRACROWN(TM) PD DENTAL ALLOY
K912493 DEGUBOND LITE
K911674 CERAPLUS
K911669 CERAPALL 6
K912308 STANDARD S32
K912307 STANDARD S31
K912305 STANDARD S3
K912302 VACU 2
K912195 PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K912194 PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
K911671 CERADELTA
K912315 V-DELTA S1
K912314 800 SOLDER
K911545 V-DELTA
K911677 SELECTOR 3
K911675 PAGALIN 2
K911668 CERAPALL 2
K912309 STANDARD S33
K912306 STANDARD S4
K912304 STANDARD S2
K912303 STANDARD S1
K912300 VS11
K912299 VS1B
K912298 VS1
K911757 MAXIBOND
K911670 CERAPALL
K910467 ARGIPLUS
K904876 DW237
K903971 ARGENCO 26B
K903060 ARGENCO 34
K903009 ARGENCO III
K902665 ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE
K902376 DW231 DENTAL ALLOY
K901099 PROTOCOL (ALLOY)
K890811 RX APF (CASTING ALLOY)
K883511 ALBABOND E
K883509 HERAEUS DG 63
K883510 DEGUPAL 4
K883507 HERAEUS C SPECIAL
K883512 HERAEUS WHITE
K874821 LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL
K873373 SINTERLOY
K871288 GDC 1830 CASTING ALLOY
K864162 DEGUPAL
K862856 PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
K860964 WHITE SILVER SOLDER AND YELLOW SILVER SOLDER
K855182 ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65
K860439 DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS
K860299 REALOR ALLOY
K860119 GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)
K852093 ALLOY 7
K852347 DENTAL CASTING ALLOY GDC 1686
K851648 HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE
K850699 SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL
K850193 PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)
K850103 GDC-1489 A CASTING ALLOY
K850102 GDC-1433 A CASTING ALLOY
K850101 GDC-1629 A CASTING ALLOY
K840563 RX C & B 20
K840561 RX ELAN
K840014 CHEMODENT CERAMIC METAL
K833774 NATURELLE II & LITE II-N72-N74-L
K833596 GDC 1448 DEVELOPMENT NAME
K833434 CERAMCO * HIGH FUSING FOIL SOLDER
K833445 DEGUPLUS 2
K833050 RX 90
K833049 PALLADENT
K832425 GREAT LAKES PASTE SOLDER
K832530 DEVA 4
K832253 X-704
K831097 CONCERTO
K831096 STROMA II
K823100 RX 91
K823097 NATURELLE
K823084 CHALLENGER
K822950 RX UNIVERSAL
K822419 NEW CROWN AND BRIDGE ALLOY NO. DW196
K821798 82 ALLOY
K821832 DEGUCAST U
K821590 PORS-ON
K821572 DUALLOR 'R'
K821510 A THENIUM
K821407 DEVA M
K821299 CER-MATE
K821022 PRECIOUS METAL ALLOYS
K820955 BOND-ON
K820530 T-IV ELITE ALLOY
K820434 CLASS OF CASTING ALLOYS TYPE III OR ALT
K820433 CLASS OF CASTING ALLOYS TYPE II OR ALTER
K820432 CLASS OF CASTING ALLOYS TYPE I OR ALTER
K820408 CLASS OF CASTING ALLOYS TYPE IV OR ALT
K820407 CLASS OF PRECIOUS METAL CASTING ALLOYS
K813418 INZOMA NP
K813200 GDC-1136 CASTING ALLOY FOR PORCELAIN-FU
K812101 BAK-ON SP PORCELAIN ALLOY
K811563 PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS
K810380 HOWMEDICA T-III G ALLOY
K801277 GDC 934
K801009 HOWMEDICA WHITE C&B ALLOY
K800951 CASTA-LLOY
K800994 AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K792274 TEMPO
K792008 HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY
K791973 HOWMEDICA A-35 DENTAL ALLOY
K791005 CHEMODENT CERAMIC METAL
K790641 GDC-685
K790097 SALIVAN & SALIVAN BROWN
K790096 SALIVAN PARAEIGHT TOUGHNESS
K771596 WILL-CERAM W-3
K771145 WILL-CERAM W-2
K760783 BIOBOND-CROWN & BRIDGE CERAMIC BONDING
K760379 DENTAL AMALGAM ALLOY (SPHERICAL II)

FEI Numbers

This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.