FDA Registration Active 🇺🇸 United States

The Argen Corporation

Reg #: 3013551048 · FEI: 3013551048 · Expires 2026
Products
14
Proprietary Names
1371
Establishment Types
6
Classifications
14

Registration Details

Registration Name
The Argen Corporation
Registration Number
3013551048
FEI Number
3013551048
Status
Active
Expiry Year
2026
Initial Importer
No
Address
8515 Miralani Drive
City
San Diego
State
CA
ZIP
92126
Country
US

Regulatory Submissions

510(k) Number
K182833

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
Powder, Porcelain EIH
Alloy, Metal, Base EJH
Abutment, Implant, Dental, Endosseous NHA
Material, Impression Tray, Resin EBH
Accessory, Surgical Apparel LYU
Aligner, Sequential NXC
Crown And Bridge, Temporary, Resin EBG
Positioner, Tooth, Preformed KMY
Resin, Denture, Relining, Repairing, Rebasing EBI
Mouthguard, Prescription MQC
Accessories, Implant, Dental, Endosseous NDP
Applicator, Absorbent Tipped, Non-Sterile KXF
Alloy, Gold-Based Noble Metal EJT
Alloy, Other Noble Metal EJS

Proprietary Names

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 Argen CoCr 255 Argen CoCr 275 Argen Titan Elite 23 Alloy: NICRALLIUM TA6V Disc Argen Ti Disc ArgenIS Titanium Abutments Argen Tray Argen Face Shield ArgenIS Angled Screw Channel (ASC) Titanium Screws ArgenIS Angled Screw Channel (ASC) Titanium Blanks ArgenIS Argen Retainer Premium Aligner Standard Argen Template Standard Argen Retainer Standard Aligner Retainer Std Argen Template Premium Aligner Template Std Aligner Template Premium Argen Aligner Premium Aligner Revision Premium Argen Aligner Rev Std Argen Aligner Rev Prem Argen Aligner Standard Aligner Revision Std Aligner Retainer Premium Aligner Premium ArgenPMMA Argen Clear Retainer JelZir HT+ ArgenZ HT+ JelZir HT+ Multilayer 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 ArgenPMMA EBG ArgenPMMA EBI ArgenPMMA MQC JelZir Anterior JelZir ST Multilayer ArgenZ Esthetic Plus ArgenZ Anterior ArgenZ ST+ ArgenZ ST ArgenZ ST Multilayer ArgenZ ST ML Argen Guide ArgenIS Torque Wrenches, ArgenIS Adapters ArgenIS Titanium Intraoral Scan Body ArgenZ GT JelZir GT Spark Aligner Nasopharyngeal Swab ArgenDS Denture Disc LWT 40 AURIUM 5 AURIUM BIO 860Y AURIUM ECO 38 AURIUM 960PF SUREBOND 500 AURIUM HP77 LOT 206 AURIUM 80 PNP 950 AURIUM 54B AURIUM E AURIUM BIO 7 DDA CAST III WILBOND YELLOW SPECIAL ARGEDENT SUPER YELLOW 87 ARGISTAR 73 AURIUM BIO 73PF CONCORD 62 LWT52SF 450-SL DDA BOND 18 AURIUM D16 WORLD YELLOW 3 YSF WILCAST 71 24 kt PENCERAM 62 WILSTAR 73 CONCORD 73LF W DAP BOND Y86 ARGENCO 10 ALBORO LF WORLD CB BIO 1 Nano Esthetic Zone P WILKADIUM SAPPHIRE BIO 1 DDA CAST I DENT-GOLD Y85PF WILBOND 2A DENT-GOLD CAST 75 ARGEDENT 51SF WILBOND BIO 78PF ARGEDENT K YPF PENCERAM 45 WILBOND BIO 89PF WORLD 45 WORLD HN FIRMILAY CONCORD 75LF 600 AURIUM 56 ARGEDENT BIO 862PF ARGENCO SUN KF 800 WORLD 2000 CONCORD 78 Posterior G B LOT SOLD WILCAST 75M ARGEDENT YELLOW 4 JEL -BURST ARGENCO HIGH PURITY 77 PENCERAM 97Y-PF JELFINE 52 JEL -4 AURIUM 55 DENT-GOLD LOT 870 LWT52 SELECT 60 WORLD 88 PENCERAM 50A BENCHMARK IV Nano Bridge & Implant P ARGEDENT 45SF ARGISTAR 598 AURIUM BIO 405 WORLD 73PF 830Y Nano Bridge & Implant G WILCAST 80 ARGISTAR 580 LWT88 LWT86 PENCAST 77Y AURIUM 810PF ARGEDENT BIO 86PF PENCERAM 75YA ARGEDENT 41 AURIUM 97 WILCAST IV WORLD 78PF 500-SL ARGISTAR 45 WILCAST 2 WILCAST 60M WILCAST 33KF PENCERAM 82Y PACIFIC 56 WORLD CB 68 ARGENCO 879 WILBOND 76 CONCORD 88 PENCAST 60Y-PF SUREBOND 54 ARGENCO BIO LIGHT AURIUM BIO 413 LWO72 LWT65 OLYMPIA ARGENCO 68 WILBOND 76SF AURIUM 73 WORLD 52SF DDA CAST BIO 1 ARGEDENT BIO 89PF WILBOND 45SF ARGENCO 20 20KT JELENKO O CAMEO W-60 WILCAST BIO 10 ARGEDENT 54 AURIUM 224 AURIUM 60M SILHOUETTE Y73 ARGENCO 75M 615 C&B (POST) LWS 73 ARGEDENT BIO 78PF WORLD 90 18 - 615 DENT-GOLD BIO 86PF WORLD 54 AURIUM BIO 402 AURIUM HP 77 High Calibration 710PF ARGEDENT 690 ARGEDENT SUPER 40 WORLD CB 40+ LWS55 PENCERAM 75YB ARTISAN ARGENCO BIO 7 ARGEDENT BIO 860Y ALLROUND POST WORLD 85PF JELBOND 65SF ARGENCO 27 ARGEDENT 45 SUREFIRE 12 ARGENCO 80 PENCAST 82Y 960PF AURIUM 2 WORLD AL2 AURIUM D69 725M AURIUM B4 WORLD CB 62 WORLD 862PF WLF WILBOND 74 AURORA 56 WILCAST 68 PENCERAM HE75Y-CF WORLD CB 63 WILBOND 87 DAP BOND AH WILBOND BIO YELLOW PF WORLD 69 AURORA 53 MODULAY DDA BOND 9 PENCERAM 53 PENCAST 63Y WG DAP BOND Y73 WILSTAR BIO 75PF LABORATORY 33 PNP ARGEDENT 40SF JELBOND PDF SUREBOND 65SF AURIUM BIO 738 PENCERAM 52A-SF WILCAST III ARGEDENT BIO 85PF ARGEDENT EC PHASER84 AURIUM C 720 830Y POST WILCAST 16 PENCERAM 81Y-PF DENT-GOLD 89 WILBOND BIO 87PF SILHOUETTE BIO 73PF AURIUM 830 WSF PHASER52 PENCERAM 40 SELECT BIO 72 Pontic Cover AUROLITE 9 850-SL PENCAST 62Y 9M ARGENCO 16 SENSATION 73 DENT-GOLD LITE 2 ARGENCO 83 ARGISTAR 86 AURIUM 410 AURIUM 55KF DAP BOND 55 Capfil Solder 520-SL ARGEDENT 62 DENT-CAST 77 MONOGRAM 3 AURIUM BIO 414 WORLD CB 52+ SUREBOND SPECIAL WILPAL 2 PENCAST 57Y WORLD 51SF ARGEDENT Y86 PENCERAM HE75Y AURIUM J WORLD HP 77 AURIUM 58 TITAN ARGENCO 883KF WILBOND 40 RAJAH SUREFIRE 10 SELECT 60 M WILCAST 70SF SILVER FREE WORLD AH ARGISAFE 570 WILBOND 98 CONCORD 72LF ARGEDENT YELLOW SPECIAL WILCAST BIO 1 ARGEDENT YELLOW 3 PENCAST 58Y-CF AURORA 52 WILCAST 58 GPLF AURIUM BIO 411 ARGENCO M1 AURIUM 887PF WORLD 84 WORLDSTAR 550 ALLROUND 4 JEL BIOS 720PF AURIUM 75M AUROLITE 40 ARGEDENT 75C DDA CAST II Capcon Powder ARGISTAR BIO 72 DENT-GOLD LOT 690 ARGENCO 75 (S.A) WILBOND BIO 86PF ARGISTAR BIO 738 WILCAST 7A WILBOND BIO 73PF ARGENCO 60Y WILCAST 883KF AURIUM AH AURIUM 239 870PF WILKORO PENCERAM 87Y-PF DENT-GOLD 72G WORLD 89 WILBOND 90 AURIUM BIO 406 CG SOLD WORLD 883KF LWS75 SILHOUETTE 500 JEL O SPECIAL GATEWAY 40 AURIUM 22KT PONTIC, #14 METAL PHASER52SF SENSATION 550 ARGISTAR 55 ARGENCO 75 DAP BOND 87 ARGEDENT QUEEN 56 ARGEDENT 70SF BIOSYSTEMIC CG II WORLD CB 83 WILBOND 84 ARGENCO 2 SILHOUETTE 75 WILBOND 52SF WILCAST 17 WORLD EURO WILCAST HIGH PURITY 77 LWO56 LWT99 WILSTAR BIO 72 ARGEDENT 2A ARGENCO BIO 11PF AURIUM 423 JELENKO O PRE WILBOND BIO SMILE WILBOND K WILCAST 6 PENCERAM 60SF DENT-GOLD 52 Lite ALLROUND SUN CENTURY CLUB RA WILBOND BIO 88 54-SL ARGEDENT 75 WILBOND YELLOW 3 WILBOND BIO 887PF ARGEDENT 66SF WILSTAR 598 ARGENCO 7A WILBOND 65SF PORCELAIN SUP POWDER ARGENCO M4 DE ORO 83 620-SL WILBOND YELLOW 2 DE ORO 97 ARGENCO 60 PARTIAL STARK PENCERAM HE73Y PENCERAM 87Y WORLD 1 615 WILBOND 54 WORLD 75 DAP BOND 74 BENCHMARK C BIO STARK PLUS DENT-GOLD LOT 1060 PENCERAM 76-SF ARGEDENT BIO 87PF ARGENCO BIO 3 ARGEDENT AH DDA BOND 12 PENCAST 75Y-H DE ORO 99 ARGEDENT 1 WILBOND 52 WORLD 74 ARGEDENT BIO 887PF WILCAST 62 PENCAST 57Y-EH ARGISTAR SUN PHASER 75 ARGEDENT 3 PENCERAM HE40Y-CF ARGISTAR BIO 75PF METEOR WORLD BIO 2 ARGENCO BIO INLAY PF ARGEDENT 52SF SPECIAL DAP STAR 73 650 C&B (POST) ARGENCO 62 1060 WILBOND 45 WORLD B YELLOW PF AURIUM D4 WILPAL 580 ALLROUND BIO 738 WORLD CB 77 WILBOND 75 ARGEDENT 40+ WORLDSTAR BIO 72 OZARK 52 PENCERAM 52 LWO75 720 (POST) JEL BIOS-10 ARGISTAR BIO 74 SENSATION 55 ARGEDENT Y73 ARGENCO 33 KF WORLD 3 SF DENT-GOLD LOT 960 WILBOND 49 UNIVERSAL BIO 75 PF DAP BOND 52 ARGEDENT BIO 82 WORLD CB 75 WORLD 60SF LABORATORY 44 ARGISTAR 550 PENCERAM 65 GOLD CORE PRE GOLDTECH (SOLDER) WCG SUPERCLASP PENCAST 61Y Y WILBOND 860Y SPECIAL INLAY SIERRA S 900-SL 650 SELECT 56 WILCAST BIO 2 Low Calibration ARGEDENT YELLOW 2 CRESCENT ARGEDENT 52 AURIUM 68M WILBOND EURO WORLD 87 WILGNATH 690PF ARGELITE 2 ARGEDENT BIO 73PF GATEWAY 50 ALLROUND 55 LF ARGISTAR BIO 69 DAP CAST 77 SUNCAST D JEL -O 75 WILBOND 60SF DAP BOND EURO DENT-GOLD LOT 800 DDA BOND 10 WORLD B 738 550-SL MONOGRAM 4 WILCAST 77 WILSTAR 55 WILCAST 20 (20CT) LWT720PF DAP BOND 52SF GATEWAY 45 WILCAST M4 DENTABOND ARGENCO 66 WILCAST 879 ARGENCO 60S WORLD 45SF AURIUM 409 DENT-GOLD 74 WILBOND 86 ARGENCO 5 WILCAST 56 400-SL AURORA 66 DIAMOND WORLD 86 ARGEDENT 90 WORLD CB 2 205 ALBORO HF Porcelain Support JELNORM LF ARGENCO 52 HN DAP CAST 75 Nano Esthetic Zone G WILCAST 40HN High Purity 77 WILBOND BIO 720PF DAP BOND 90 1040 PENCAST 60Y ARGENCO 71 COLLEGIATE WORLD 76SF AURORA 56LF WORLDSTAR 55 SUREBOND DENT-GOLD 98 WILCAST 52HN AURIUM BIO 212 CONCORD 90 DE ORO 77 DAP CAST 56 WILCAST 75 ARGEDENT 87 WILCAST 63 ARGEDENT 74 WORLD 98 ARGEDENT 60SF CN AURIUM BIO 422 AURIUM BIO 403 AURIUM 52HN WORLD 52 WILCAST M1 210 WILBOND BIO 860Y WILBOND BIO 85PF WILBOND Y73 JEL -BIOS 86 SIERRA M WILBOND 41 ARGENCO BIO 2 GATEWAY 74 ARGENCO 12 ARGEDENT BIO YELLOW PF DAP BOND 65SF ARGEDENT 65SF PACIFIC 68 PENCAST 73Y-CF ARGEDENT HN SENSATION YELLOW JEL-BIOS 90 OLYMPIA PRE 890-SL DENT-GOLD AH ARGENCO 77 SILFREE 45 410-SL WILBOND BIO 862PF DENT-GOLD 525 WILBOND 40SF ARGEDENT SUPER HARD WORLD CB 56 AURIUM D17 SILHOUETTE 74 WILBOND 69 Inconnect Powder DDA BOND 20 WORLD 500 SPECIAL OLYMPIA-LITE WILCAST BIO 7 WILSTAR 45 ARGEDENT 81 ARGEDENT BIO 720PF WILCAST NORDIC 18 - 650 PENCAST 75Y AURIUM SG Posterior P UCP Powder PTM-45 WILBOND EC SILHOUETTE 405 WILBOND AH DAP STAR BIO 75PF WILSTAR BIO 74 ARGENCO 17 DAP BOND BIO 89PF AURIUM A WILCAST 60 III PHASER 88PF JEL -96 SELECT 75M WILNORM ARGEDENT EURO AURIUM BIO 720PF WILBOND BIO 88PF AURIUM EURO ARGEDENT 98 AURIUM BIO 404 WILTEX AURIUM 1030PF WORLD 65SF LWS73 WILBOND 690 WILBOND HN AURORA 75 Nano Universal G 760 PENCERAM 84Y AURIUM 98 ARGENCO 58 WILCAST 4 BENCHMARK III ARGEDENT JK ARGENCO 60M 750-SL AURIUM 86 DENT-GOLD Y73 WORLDSTAR 73 WORLD CB 71 DENT-GOLD 87 SILHOUETTE 65SF CONCORD 87 1030PF ARGEDENT NOVABOND WORLD CB 58 AURIUM BIO 301 WORLDSTAR BIO 75 CONCORD 82 PEN 22KT GOLD INGOTS ARGEDENT 69 AURIUM YPF LWO33 810PF GOLDTECH BIO 2000 800 Fine High Noble Metal Based Dental Alloy Family 209 LWS72 WILBOND BIO 880PF WILCAST 40KF EUREKA PLUS ARGENCO BIO 1 JELENKO EC LWO77 ARGEDENT BIO SMILE LWT89 PENCAST 68Y 600 (PRE) 800W 660 SOLD JEL -BIOS 18 AURIUM 550 JELBOND Y73 JELENKO NO. 2 WIRE WILSTAR BIO 738 PENCERAM 74Y AURIUM 3 DENT-GOLD 73 WILBOND 1 DDA CAST V WILBOND 85 ARGENCO 6 CONCORD 81 WILBOND 52SF SPECIAL LITE BIOSYSTEMIC IV ALLOY FOR SINTERKOR SELECT 92 WILCAST 27 204 LWT84 JEL -62 DENT-GOLD 84 Inflow Powder ARGENCO 68M ARGENCO 4 WILBOND 62 WILCAST 60 SUREBOND 66SF ARGEDENT 76 ARGEDENT 500 22 - 750 AURIUM BIO 82 WORLD 62 P ARGINORM DENT-GOLD BIO 880PF PENCAST 84Y 980 ARGENCO 60 III WILBOND 500 800PF WILCAST 68M ARGEDENT YELLOW 1 PENCAST 50Y-EH CONCORD 86 770PF ARGENCO 63 PENCERAM 77 ARGENCO 56 MONOGRAM 2 490-SL 740-SL DENT-GOLD NORM ARGEDENT 76SF LWT87 AUROLITE 45 PENCERAM 86Y-PF WILCAST 5 615 FINE ARGEDENT LIBERTY PENCERAM HE74Y ARGENCO 77G ALLROUND PRE WILBOND 3 DENT-GOLD 75 WILBOND 505 ARGEDENT BIO 88 WILCAST 12 WILCAST BIO INLAY PF 615 FINE SOLD ARGENCO 40 HN DENT-GOLD CAST 68 ARGEDENT 49 JEL-BIOS 99+ 24KT ALLOY KIT WORLD CB 60 DDA BOND 30 ARGEDENT ULTRA SPEC WILCAST BIO LIGHT WILCAST 83 MONOGRAM 1 SUREFIRE 50 SUREBOND 52 700-SL PDF PRE CAMEO PRE AURIUM Y73 PENCERAM 68-SF PENCERAM 52SF ARGEDENT 505 ARGENCO A3 WILBOND 51SF ARGEDENT 52SF WILBOND YELLOW 4 208 LWT77 LM POST GATEWAY 88 Build Up Powder WILBOND YELLOW 1 JELENKO # 7 AURORA 50 ARGEDENT BIO 880PF AURORA 69 WORLD 85 ARGEDENT PM-5 AUROLITE 41 880-SL Nano Universal P ARGEDENT 40 Argen Flex JelZir Ultra ArgenZ Ultra ArgenZ Esthetic 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 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

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility