Manufacturer registered with FDA
The Argen Corporation
San Diego, CA, United States. Lists 11 dental device types with FDA across 2 registered establishments, and holds 11 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 1,372
- 510(k) clearances
- 112007–2024
- Markets registered in
- 11288 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name The Argen Corporation as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | The Argen Corporation | 11 clearances | 2007–2024 | Below |
| Canada | Health Canada | Registration holder | THE ARGEN CORPORATION | 182 | 1999–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | The Argen Corporation | 26 | 1998–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | THE ARGEN CORPORATIONThe Argen Corporation | 22 | 2008–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | The Argen Corporation | 20 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | THE ARGEN CORPORATION | 12 | — | Pure Global AI |
| China | NMPA | Registration holder | 美国阿根公司The Argen Corporation美国阿根公司THE ARGEN CORPORATION | 10 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | The Argen Corporation | 5 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | The Argen Corporation | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | The Argen Corporation | 4 | 2004–2015 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | The Argen Corporation | 2 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What The Argen Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ArgenISArgenIS Angled Screw Channel (ASC) Titanium BlanksArgenIS Angled Screw Channel (ASC) Titanium ScrewsArgenIS Titanium Abutments | 2016 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | ArgenZ AnteriorArgenZ Color ModifierArgenZ EstheticArgenZ Esthetic PlusArgenZ GTArgenZ HT+ArgenZ Incisal EffectArgenZ Liquid Shade HTArgenZ Liquid Shade STArgenZ Pontic Reducer 18 moreArgenZ STArgenZ ST MLArgenZ ST MultilayerArgenZ ST+ArgenZ Tissue ShadeArgenZ UltraJelZir AnteriorJelZir GTJelZir HT+JelZir HT+ MultilayerJelZir ST MultilayerJelZir UltraZirconia Color ModifierZirconia Incisal EffectZirconia Liquid Shade HTZirconia Liquid Shade STZirconia Pontic ReducerZirconia Tissue Shade | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | ArgenPMMAArgenPMMA EBGArgenPMMA EBIArgenPMMA MQC | 2014 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | ArgenDS Denture DiscArgenPMMA EBGArgenPMMA EBIArgenPMMA MQC | 2020 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | ALBA LITEAlloy: NICRALLIUM TA6V DiscARGELOY ECO-C&BARGELOY ECO-C&B (A)ARGELOY N.P.ARGELOY N.P. (Be-Free)ARGELOY N.P. APEXARGELOY N.P. BONDARGELOY N.P. BOND VARGELOY N.P. COSMO 154 moreARGELOY N.P. ELITEARGELOY N.P. SPECIALARGELOY N.P. STARARGELOY N.P. SUPREMEARGELOY N.P.(V)ARGELOY PARTIALARGELOY SUNRAYARGELOY YELLOW C&BArgen CoCr 255Argen CoCr 275Argen Ti DiscArgen Titan Elite 23ARGENCO 23ARGENCO W-LITEARGI-SILVERAURILOY 80AURILOY N.P. APEXAURILOY N.P. ELITEAURILOY N.P. SUPREMEAURILOY NPAURILOY NP ( Be-Free)AURILOY NP (Special)AURILOY NP BONDAURILOY NP STARAURILOY NP VAURILOY PARTIALAURILOY SUNRAYAURIUM 830WAUROLOY PARTIAL +CBYCo/Cr PreCOMMENDCOMMEND NBCOMMEND VDAP CAST W-LITEDAP XDDA BOND PC NP SPECIALDENT-GOLD LOT 835DENT-GOLD NP BONDDENT-GOLD NP VDISCOVERYFlux N-SolFULL CAST WHTGENESIS IIGER ARGENCO W-LITEGER ARGESOL 750WGER ARGESOL 830WGOLD CORE PLUSHF SOLDERJDJD ALLOY INDUCTIONJD TORCHJELBOND ALTOJELBOND BJELBOND BFJELBOND CJELBOND CVJELBOND PARTIALJELBOND PREMIERJELBOND SUPERJELBOND SUPREMEJELBOND TOTALJELCAST CITRINEJELCAST YCBJELENKO JEWELCAST+JEWEL CAST PLUSJNP SOLDER STRIPLFLWNPCoLWNPNiNNPNOVAREXNPNP (PRE)NP Co/Cr LWNP Ni/Cr LWNP Pre SolderNP SOLDERNPV LE (lb)PARTIAL HARDPENCAST P22PHASER NP Co/Cr LWREX 4REX CCREX WREXALLOYRexillium IIIREXILLIUM NBFRexillium VSELECT LITESELECT SUNRAYSENSATION NP LFSILHOUETTE N.P (Partial)SILHOUETTE N.P.SILHOUETTE N.P. (Be-Free)SILHOUETTE N.P. (Special)SILHOUETTE N.P. STARSILHOUETTE N.P. SUPREMESILHOUETTE N.P.(V)SILHOUETTE NP APEXSILHOUETTE NP BONDSILHOUETTE NP BOND VSILHOUETTE NP PARTIALSLM Laser FlexSLM Premier PowderSPLINT-SILVER 90SUNBURSTSUPER 1SUPER 10SUPER 100SUPER 11SUPER 12SUPER 12 PLUSSUPER 13SUPER 14SUPER 3SUPER 3 ECONOMYSUPER 4SUPER 40Super 50SUPER 6SUPER 6 PREMIUMSUPER 7SUPER 8SUPER 80SUPER PRE-SOLDERSUPERCAST CCSUPERCAST HIGH-GRADESUPRACHROMESUPRACHROME +TECHCASTTRILLIUMTYTANIUM R/2WC BONDWILBOND N.P. (Be-Free)WILBOND N.P. BONDWILBOND N.P. PARTIALWILBOND N.P. SPECIALWILBOND N.P. STARWILBOND N.P. SUPREME | 1998 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | ACCU-STARALBACASTALLROUND 37ALLROUND 38ALLROUND EAMETHYSTAREGSOL STEELARGEBOND 77+ARGEBOND 80ARGEDENT 30 403 moreARGEDENT 35SFARGEDENT 38ARGEDENT TRENDYARGELITE 3ARGELITE 49ARGELITE 50ARGELITE 51LARGELITE 52+ARGELITE 54+ARGELITE 54BARGELITE 55ARGELITE 57ARGELITE 57+ARGELITE 58PARGELITE 59ARGELITE 60ARGELITE 60+ARGELITE 60PARGELITE 61ARGELITE 61+3ARGELITE 63+4ARGELITE 70+ARGELITE 71ARGELITE 75+6ARGELITE 75SFARGELITE 76+ARGELITE 76SF+ARGELITE 78+6ARGELITE 78SFARGELITE 80+5ARGELITE 80SFARGELITE 80SF+ARGELITE 81SF+ARGELITE 85ARGELITE AARGELITE PF+ARGELITE SR+ARGENCO 10SARGENCO 18ARGENCO 20ARGENCO 25ARGENCO 26ARGENCO 30ARGENCO 31ARGENCO 333ARGENCO 34ARGENCO 36ARGENCO 40ARGENCO 41ARGENCO 42ARGENCO 43ARGENCO 46ARGENCO 50ARGENCO 50 CARGENCO 50 IVARGENCO 52ARGENCO 9ARGENCO CAST FITARGENCO MARGENCO WARGENCO W+ARGENCO WLFARGENCO WR+ARGENCO Y+ARGICRAFT 2ARGIPALARGIPLUS (Japan)ARGISTAR 37ARGISTAR 38ARGISTAR 40ARGISTAR 43+ARGISTAR EARGISTAR YELLOW LFAURIUM 20%AURIUM 30AURIUM 30 IMPLANTAURIUM 50%AURIUM 50CAURIUM 50YAURIUM 750YAURIUM 78+6AURIUM CBAURIUM D37AURIUM D40AURIUM D43AURIUM DWAURIUM G13AURIUM G14AURIUM G15AURIUM MAURIUM W+AURIUM WHITEAURIUM X6AURIUM Y+AURIUM YELLOW LFCELEBRITYCOMETDAP CAST 20DAP CAST 40DAP CAST 46DAP CAST W+DAP CAST Y+DAP MDAP NOBLE NFDAP PALLA 49DAP PALLA 60+DAP PALLA 61DAP PALLA 76SF+DAP STAR 40DDA CAST XVDENT-GOLD 38DENT-GOLD 82PDENT-GOLD CAST 20DENT-GOLD CAST 40DENT-GOLD CAST 50IVDENT-GOLD CAST WDENT-GOLD CAST WR+DENT-GOLD LIGHTDENT-GOLD LITE 3DENT-GOLD LITE 50DENT-GOLD LITE 52+DENT-GOLD LITE 54BDENT-GOLD PLUSDISCOVERYESTHETIC YELLOWFORTICASTFREEDOMFREEDOM PLUSGER 14KT PLATEGER ARGELITE 52+GER ARGELITE 54BGER ARGELITE 55GER ARGELITE 58PGER ARGELITE 61GER ARGELITE 61+GER ARGELITE 70+GER ARGELITE 75+6GER ARGELITE 78+GER ARGELITE 80SF+GER ARGELITE 81SF+ | 1992 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Argen Clear RetainerArgen Flex | 2020 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Aligner PremiumAligner Retainer PremiumAligner Retainer StdAligner Revision PremiumAligner Revision StdAligner StandardAligner Template PremiumAligner Template StdArgen Aligner PremiumArgen Aligner Rev Prem 7 moreArgen Aligner Rev StdArgen Aligner StandardArgen Retainer PremiumArgen Retainer StandardArgen Template PremiumArgen Template StandardSpark Aligner | 2020 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | Argen Tray | 2022 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | ALBORO HFALBORO LFALLOY FOR SINTERKORALLROUND 4ALLROUND 55 LFALLROUND BIO 738ALLROUND POSTALLROUND PREALLROUND SUNARGEDENT 1 722 moreARGEDENT 2AARGEDENT 3ARGEDENT 40ARGEDENT 40+ARGEDENT 40SFARGEDENT 41ARGEDENT 45ARGEDENT 45SFARGEDENT 49ARGEDENT 500ARGEDENT 505ARGEDENT 51SFARGEDENT 52ARGEDENT 52SFARGEDENT 52SF SPECIALARGEDENT 54ARGEDENT 60SFARGEDENT 62ARGEDENT 65SFARGEDENT 66SFARGEDENT 69ARGEDENT 690ARGEDENT 70SFARGEDENT 74ARGEDENT 75ARGEDENT 75CARGEDENT 76ARGEDENT 76SFARGEDENT 81ARGEDENT 87ARGEDENT 90ARGEDENT 98ARGEDENT AHARGEDENT BIO 720PFARGEDENT BIO 73PFARGEDENT BIO 78PFARGEDENT BIO 82ARGEDENT BIO 85PFARGEDENT BIO 860YARGEDENT BIO 862PFARGEDENT BIO 86PFARGEDENT BIO 87PFARGEDENT BIO 88ARGEDENT BIO 880PFARGEDENT BIO 887PFARGEDENT BIO 89PFARGEDENT BIO SMILEARGEDENT BIO YELLOW PFARGEDENT ECARGEDENT EUROARGEDENT HNARGEDENT JKARGEDENT KARGEDENT LIBERTYARGEDENT NOVABONDARGEDENT PM-5ARGEDENT QUEEN 56ARGEDENT SUPER 40ARGEDENT SUPER HARDARGEDENT SUPER YELLOW 87ARGEDENT ULTRA SPECARGEDENT Y73ARGEDENT Y86ARGEDENT YELLOW 1ARGEDENT YELLOW 2ARGEDENT YELLOW 3ARGEDENT YELLOW 4ARGEDENT YELLOW SPECIALARGELITE 2ARGENCO 10ARGENCO 12ARGENCO 16ARGENCO 17ARGENCO 2ARGENCO 20 20KTARGENCO 27ARGENCO 33 KFARGENCO 4ARGENCO 40 HNARGENCO 5ARGENCO 52 HNARGENCO 56ARGENCO 58ARGENCO 6ARGENCO 60ARGENCO 60 IIIARGENCO 60MARGENCO 60SARGENCO 60YARGENCO 62ARGENCO 63ARGENCO 66ARGENCO 68ARGENCO 68MARGENCO 71ARGENCO 75ARGENCO 75 (S.A)ARGENCO 75MARGENCO 77ARGENCO 77GARGENCO 7AARGENCO 80ARGENCO 83ARGENCO 879ARGENCO 883KFARGENCO A3ARGENCO BIO 1ARGENCO BIO 11PFARGENCO BIO 2ARGENCO BIO 3ARGENCO BIO 7ARGENCO BIO INLAY PFARGENCO BIO LIGHTARGENCO HIGH PURITY 77ARGENCO M1ARGENCO M4ARGENCO SUN KFARGINORMARGISAFE 570ARGISTAR 45ARGISTAR 55ARGISTAR 550ARGISTAR 580ARGISTAR 598ARGISTAR 73ARGISTAR 86ARGISTAR BIO 69ARGISTAR BIO 72ARGISTAR BIO 738ARGISTAR BIO 74ARGISTAR BIO 75PFARGISTAR SUNARTISANAURIUM 1030PFAURIUM 2AURIUM 224AURIUM 22KTAURIUM 239AURIUM 3AURIUM 409 | 1992 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Argen GuideArgenIS Titanium Intraoral Scan BodyArgenIS Torque Wrenches, ArgenIS Adapters | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names The Argen Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Oct 2024 | K242458 | ArgenZ MTZ | EIH Porcelain Powder |
| 10 Feb 2020 | K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | NXC Sequential Aligner |
| 7 Jun 2019 | K183229 | Argen Clear Aligner | NXC Sequential Aligner |
| 12 Apr 2019 | K190079 | ArgenZ HT+ | EIH Porcelain Powder |
| 8 Feb 2019 | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | EIH Porcelain Powder |
| 18 May 2018 | K172430 | ArgenIS Titanium Abutments | NHA Endosseous Dental Implant Abutment |
| 5 Aug 2016 | K160248 | ArgenIS Titanium Abutments | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2015 | K143051 | ArgenIS Titanium Abutments | NHA Endosseous Dental Implant Abutment |
| 13 Jul 2015 | K150919 | ArgenZ Esthetic Plus | EIH Porcelain Powder |
| 31 Jul 2014 | K140894 | ARGEN PMMA | EBG Resin Temporary Crown and Bridge |
| 15 Aug 2007 | K071410 | ARGEN PEARL BRAND ZIRCONIA | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: MyoHealth Technologies, LLC (1).
Also lists devices cleared under other names
The Argen Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Terrats Medical, S.L. (1), Huge Dental Material Co., Ltd. (1), Mycone Dental Supply Company, Inc. (Aka Keystone Industries) (1), Nt-Trading GmbH and CO KG (1), Dental Alloy Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Apr 2024 | K240208 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 3 Nov 2020 | K201683 | PMMA Block | Huge Dental Material Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 27 Apr 2018 | K172764 | Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | EBI Rebasing Repairing Relining Denture Resin |
| 17 Feb 2012 | K111935 | TI-BASE ABUTMENT, 1 CONNECT ABUTMENT | Nt-Trading GmbH and CO KG | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2000 | K002302 | SUPER 14 | Dental Alloy Products, Inc. | EJH Base Metal Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| The Argen CorporationFDA reg. 3013551048 | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer |
| THE ARGEN CORPORATIONFDA reg. 2433919 | SAN DIEGO, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9021799). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.