Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013551048

FEI Number

3013551048

Entity Name

The Argen Corporation

City/State/Country

San Diego, CA, US

Establishment Address

8515 Miralani Drive, San Diego, CA 92126, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

The Argen Corporation (Owner Number: 9021799)

Owner / Operator Contact Address

5855 Oberlin Drive, --, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 ArgenIS Titanium Abutments ArgenIS Titanium Abutments ArgenIS 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 ArgenIS ArgenIS 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 ArgenIS ArgenZ GT JelZir GT ArgenIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2019-03-21
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2023-04-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-09-05
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-05-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-03-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-12-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-08-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-07-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-12-28
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2020-03-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-06-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2014-10-03
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2020-11-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2019-04-12
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	1998-07-16
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-04-23
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-04-23
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2024-04-23
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-06-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-05-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-11

Official Correspondent

Wendy Felix

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Argen Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2433919	THE ARGEN CORPORATION	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013551048. Last updated year: 2026. Please use registration number 3013551048 when referencing this establishment in official correspondence.