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
Abutment, Implant, Dental, Endosseous NHA
Powder, Porcelain EIH
Alloy, Metal, Base EJH
Crown And Bridge, Temporary, Resin EBG
Alloy, Other Noble Metal EJS
Resin, Denture, Relining, Repairing, Rebasing EBI
Mouthguard, Prescription MQC

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