FDA Registration
Active
🇺🇸 United States
THE ARGEN CORPORATION
Reg #: 2433919
·
FEI: 2433919
·
Expires 2026
Products
7
Proprietary Names
608
Establishment Types
5
Classifications
7
Registration Details
- Registration Name
- THE ARGEN CORPORATION
- Registration Number
- 2433919
- FEI Number
- 2433919
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5855 Oberlin Dr
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150919
Owner / Operator
- Firm Name
- The Argen Corporation
- Operator Number
- 9021799
- Address
- 5855 Oberlin Drive, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Wendy Felix
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-03-11 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-06-30 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 1998-07-16 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2014-10-03 |
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 1992-11-24 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2024-04-23 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-04-23 |
Proprietary Names
ArgenIS
JelZir Anterior
JelZir ST Multilayer
ArgenZ Esthetic Plus
ArgenZ Anterior
ArgenZ ST+
ArgenZ ST
ArgenZ ST Multilayer
ArgenZ ST ML
JelZir Ultra
ArgenZ Ultra
ArgenZ Esthetic
SLM Laser Flex
SLM Premier Powder
NP SOLDER
AUROLOY PARTIAL +
WILBOND N.P. (Be-Free)
DENT-GOLD NP V
SUPRACHROME
ARGI-SILVER
ARGELOY N.P. COSMO
JELBOND PARTIAL
REX W
SUPERCAST HIGH-GRADE
WC BOND
AURILOY SUNRAY
AURILOY NP ( Be-Free)
JELCAST CITRINE
Co/Cr Pre
HF SOLDER
SUPER PRE-SOLDER
SUPER 6 PREMIUM
WILBOND N.P. SPECIAL
COMMEND V
TECHCAST
SELECT LITE
SILHOUETTE NP BOND
AURILOY NP BOND
SILHOUETTE N.P.(V)
SENSATION NP LF
SILHOUETTE N.P. STAR
ALBA LITE
AURILOY NP (Special)
SPLINT-SILVER 90
ARGELOY N.P. BOND V
SUPER 14
Flux N-Sol
JD
SELECT SUNRAY
WILBOND NP
ARGELOY SUNRAY
WILBOND N.P. PARTIAL
SUPER 11
REXILLIUM NBF
GER ARGESOL 750W
GER ARGENCO W-LITE
DDA BOND PC NP SPECIAL
ARGELOY N.P. (Be-Free)
TYTANIUM R/2
SUPER 12 PLUS
830W
DENT-GOLD LOT 835
AURILOY NP V
NPV LE (lb)
JELBOND C
WORLD APEX
SUPER 12
DAP CAST W-LITE
Rexillium V
ARGENCO 23
SUPER 13
SUPER 8
JELCAST YCB
SUPER 80
ARGELOY ECO-C&B (A)
WILCAST W LITE
NP
JD TORCH
GOLD CORE PLUS
JELBOND TOTAL
NP (PRE)
COMMEND
ARGELOY N.P. SPECIAL
PARTIAL HARD
NP Pre Solder
WILBOND N.P. STAR
JELBOND BF
SUPER 1
ARGELOY N.P. STAR
SUPER 7
SILHOUETTE NP BOND V
ARGELOY PARTIAL
ARGELOY ECO-C&B
LF
ARGENCO W-LITE
AURILOY N.P. SUPREME
NP Co/Cr LW
LWNPNi
SILHOUETTE N.P. (Special)
WILBOND SUNRAY
NNP
JNP SOLDER STRIP
SUPER 6
AURILOY NP STAR
JEWEL CAST PLUS
NP Ni/Cr LW
AURILOY N.P. ELITE
REX 4
JELBOND SUPER
TRILLIUM
YELLOW C&B
SUPER 4
WILBOND N.P. BOND
GER ARGESOL 830W
REX CC
LWNPCo
CBY
AURIUM 830W
JELBOND B
Super 50
COMMEND NB
WILBOND N.P. SUPREME
NOVAREX
SUPER 40
WILBOND NP V
WILBOND YELLOW C&B
SILHOUETTE N.P. SUPREME
FULL CAST WHT
750W
SUNBURST
PHASER NP Co/Cr LW
ARGELOY N.P. APEX
ARGELOY N.P.(V)
AURILOY PARTIAL
JELBOND PREMIER
DAP X
Rexillium III
SUPER 3
SILHOUETTE N.P.
ARGELOY N.P. BOND
DENT-GOLD NP BOND
ARGELOY YELLOW C&B
SUPERCAST CC
JD ALLOY INDUCTION
SILHOUETTE N.P. (Be-Free)
SUPRACHROME +
REXALLOY
ARGELOY N.P.
DISCOVERY
WILCAST 23
JELBOND CV
SILHOUETTE NP APEX
WORLD NP
WORLD UNI METAL V
SILHOUETTE N.P (Partial)
AURILOY 80
SUPER 3 ECONOMY
SUPER 100
SUPER 10
GENESIS II
JELENKO JEWELCAST+
JELBOND SUPREME
JELBOND ALTO
WORLDSTAR
ARGELOY N.P. SUPREME
WILCAST SUNRAY
SILHOUETTE NP PARTIAL
PENCAST P22
AURILOY N.P. APEX
AURILOY NP
ARGELOY N.P. ELITE
ArgenZ GT
JelZir GT
JelZir HT+
ArgenZ HT+
JelZir HT+ Multilayer
ArgenIS Angled Screw Channel (ASC) Titanium Screws
ArgenIS Angled Screw Channel (ASC) Titanium Blanks
ArgenPMMA
ArgenIS Titanium Abutments
PEN PLATINUM FOIL 01
AURIUM WHITE
AURIUM YELLOW LF
AURIUM 30 IMPLANT
LWT 80
Noble Metal Based Dental Alloy Family
LIBERTY
GER ARGENCO WR+
ARGENCO 42
ARGENCO 34
750Y PRE
NATURELLE KF
AURIUM 750Y
WILCAST 50 IV
JELSTAR
LWT80
ARGELITE 76+
SENSATION 38
GER ARGISTAR 37
JEL -5
PVS PLATINUM FOIL
DAP PALLA 61
PENCAST 42Y
SILFREE 80SF+
GER ARGESOL P
WILPAL 80+5
GER ARGENCO 30
PALLADIA 76
DENT-GOLD CAST 50IV
WORLDSTAR YLF
SILFREE 79+
ARGELITE 57
LO
ARGISTAR 43+
WORLD CB 52
JELSTAR 71
ARGELITE 70+
ARGEDENT TRENDY
COMET
ALLROUND 37
ARGEBOND 77+
PENCAST 52Y
PENCAST 40Y
WILPAL 76SF+
PENCERAM P79A-SF
JELSTAR 63+4
SILHOUETTE 110SL
WILCAST 50
ARGELITE 51L
WORLD 35SF
AMETHYST
ARGELITE 3
DAP PALLA 49
ARGISTAR 40
GER ARGIPAL
PENCERAM 13
PENCERAM 06
DENT-GOLD LITE 54B
WILPAL 81SF+
ARGIPAL
R
AURIUM DW
DENT-GOLD CAST WR+
PENCERAM P77B-SF
DAP CAST 40
WILPAL 52+
ARGELITE 57+
WILBOND 38
LWL54
SELECT 40
GER ARGESOL LO STRIP
ACCU-STAR
18 - 585
JEL 15
WILCAST 41
WILPAL 54+
PEN JEWELRY GOLD Rx 14kt
750Y
AURIUM 50C
AURIUM CB
GER 14KT PLATE
WILPAL 80SF+
ARGELITE 75+6
14K
DENT-GOLD 38
PIEDMONT 70
OSAGE 76
SELECT 50
110-SL
AURIUM 20%
ARGIPLUS (Japan)
WILPAL 80
AURIUM Y+
WILCAST 9
PENCERAM HE02Y-CF
PAGEANT
DAP CAST 46
150-SL
DAP CAST Y+
WILPAL 60P
PACIFIC 50
PENCAST P25-CF
GER ARGENCO 36
LEGEND 80SF
WILCAST 25
PHASER60P
ARGELITE 58P
LEGEND 61
SILFREE 80SF
250-SL
SUNCAST
GER ARGELITE 55
WILCAST M
LEGEND 85
NOBLECROWN NF
OZARK 50
GER ARGELITE 70+
ALLROUND 38
GER ARGELITE 52+
ARGENCO 25
ARGENCO WR+
300-SL
180-SL
ALLROUND E
LEGEND 77+
PLATINUM
SELECT WR+
ARGELITE 60P
270-SL
DENT-GOLD PLUS
JEL-40
ARGENCO 20
ARGISTAR E
AURIUM M
W
PENCERAM P79B-SF
LEGEND 60P
NOBLECROWN
WILPAL 59
CELEBRITY
AURIUM G14
280-SL
ARGELITE 61
DAP CAST W+
585 FINE
PALLADIA 85
AURIUM 50Y
PENCERAM P80
ARGENCO M
WILPAL SR+
WILCAST 52
ARGELITE 60+
GER ARGISTAR 38
LEGEND +2
ARGISTAR YELLOW LF
ARGENCO 50
ARGENCO 46
LEGEND 52+
LO/450 C&B POST
LA PLATA 40
WILCAST 46
Z29
SILFREE
LWS40
ARGENCO 9
DAP CAST 20
WILBOND 35SF
ARGENCO WLF
GER ARGELITE 81SF+
WILCAST WR+
WILPAL PF+
ARGEDENT 30
OZARK 20
100-SL
LWL75
ARGELITE 63+4
PENCAST 45Y
ARGENCO 50 C
PALECO
MAESTRO
OSAGE 80
ARGENCO 41
ARGENCO 31
ARGISTAR 37
ARGELITE 76SF+
ARGENCO 18
WORLD 26
P (PRE)
LWL61
DDA CAST XV
PENCAST 47Y
GER ARGENCO Y+
585 Fine
GER ARGELITE 78+
DENT-GOLD LITE 52+
ARGENCO 36
NOBLE W
GER ARGI SAFE 63+
ARGELITE 78+6
WILPAL 60+
WILCAST 18
WORLDSTAR 40
WORLD CB 27+
DENT-GOLD LIGHT
585
OZARK 40
ARGELITE 71
ARGELITE 60
ARGELITE 54B
Jel 55
AURIUM 78+6
PENCERAM P54A
ARGENCO 30
ARGISTAR 38
DAP STAR 40
500
PAGEANT+
AURIUM D43
ARGELITE 85
LWL60
14 - 437
GER ARGELITE 75+6
GER TOPCAST
ARGEBOND 80
ARGELITE 78SF
LEGEND 55
GER ARGELITE 61
WILPAL 85
ESTHETIC YELLOW
SELECT WLF
WILCAST W
ARGELITE 75SF
LEGACY
DENT-GOLD LITE 3
R/1200 C&B POST
AURIUM G15
WILCAST 50C
PENCERAM P50
ARGENCO Y+
WILPAL 50
WILCAST 42
3K
FORTICAST
ARGELITE 52+
SUNRAY
GER ARGENCO WLF
GER ARGELITE 54B
GER ARGISTAR 40
GER AS STAHLGOLDLOT 750
ARGENCO 40
DAP M
WILPAL A
WILCAST 40
WILCAST 333
WORLD CB 20
PERFECT FIT+
206
SUREFIRE PF+
PENCAST 50Y
FREEDOM
LEGEND 75+
WILPAL 70+
ARGENCO W
LA PLATA 39
SILFREE 2
DENT-GOLD CAST 20
GOLD CORE POST
PENCERAM P77A-SF
AREGSOL STEEL
DAP NOBLE NF
AURIUM 30
WILPAL 61
AURIUM D37
DENT-GOLD LITE 50
WORLD CB 25
585 C&B (POST)
PALLADIUM 432
PENCAST 20Y-CF
SELECT 10
WILPAL 49
GOLD CORE 38
WILCAST W+
WILPAL 75+6
GER ARGIPLUS
ARGEDENT 35SF
500 FINE
DENT-GOLD CAST W
PENCERAM P76-SF
SENSATION WHITE
GER ARGIPLUS 2
ARGENCO 10S
ARGENCO 43
SELECT 46
WILPAL 77+
LPF+
GER ARGENCO 34
OLYMPIA II
ALBACAST
WILCAST 36
ARGELITE 50
DAP PALLA 60+
WILPAL 61+3
SUREFIRE S
WILPAL 78SF
PENCAST P25
ARGELITE 80SF+
WILPAL 54B
SUREFIRE A
MAXIBOND 2
DENT-GOLD 82P
LWS38
TOPCAST
ARGENCO 52
SELECT Y+
PALLADIA 75
LEGEND 60+
WORLDSTAR 38
WORLD CB 25+
MICRO-STAR
ARGELITE 55
WORLD CB 50
NOBLEBOND
ARGELITE A
SELECT 20
GER ARGENCO M
GER ARGELITE 61+
LEGEND 76+
GER ARGESOL 750Y
ARGELITE SR+
ARGELITE 49
WORLD AL3
GER ARGELITE 80SF+
170-SL
LEGEND 58P
SILHOUETTE 49
GER ARGENCO 9
AURIUM X6
SELECT W+
WILCAST 20
155-SL
TAOS 28
ARGEDENT 38
AURIUM D40
ARGENCO 50 IV
P
LEGEND 80+
FREEDOM PLUS
LEGEND
WILCAST Y+
WILPAL 63+4
WILPAL 60
SILFREE 79
MEDALIST
GER SIM CAST S88
DAP PALLA 76SF+
ARGELITE PF+
OZARK 2
GER ARGICRAFT 2
ARGENCO W+
LEGEND 60
AURIUM 50%
LA PLATA 34
OZARK 46
ARGELITE 80SF
ARGELITE 54+
DENT-GOLD CAST 40
SELECT WHITE
ARGICRAFT 2
WILSTAR 40
ARGENCO 26
WILPAL 80SF
SUPER-STAR
PHASER80
PENCERAM P61
171-SL
GER ARGELITE 58P
SUNLIGHT
285-SL
JELCROWN NF
WILPAL 76+
WORLD CB 43
ARGELITE 81SF+
104-SL
GOLDSTAR
PENCERAM P54B
SELECT 52
ARGELITE 80+5
AURIUM W+
175-SL
W-50
ARGENCO 333
WILPAL 3
115-SL
ARGELITE 61+3
583
WILCAST WLF
WILPAL 58P
PROSPECTOR PLUS
ARGELITE 59
LWL58
ARGENCO CAST FIT
MIDAS
OSAGE 81
W PAGEANT
AURIUM G13
200-SL
GER ARGENCO W
PENCERAM P58
WILPAL 55
ORBIT
LA PLATA 28
WORLD CB 46
WORLD CB 40
ArgenZ Tissue Shade
Zirconia Liquid Shade ST
ArgenZ Liquid Shade HT
ArgenZ Liquid Shade ST
ArgenZ Color Modifier
ArgenZ Incisal Effect
ArgenZ Pontic Reducer
Zirconia Tissue Shade
Zirconia Incisal Effect
Zirconia Pontic Reducer
Zirconia Color Modifier
Zirconia Liquid Shade HT
ArgenPMMA EBG
ArgenPMMA EBI
ArgenPMMA MQC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198