THE ARGEN CORPORATION

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 2433919

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2433919
FEI Number
2433919
Entity Name
THE ARGEN CORPORATION
City/State/Country
SAN DIEGO, CA, US
Establishment Address
5855 Oberlin Dr, SAN DIEGO, CA 92121, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
The Argen Corporation (Owner Number: 9021799)
Owner / Operator Contact Address
5855 Oberlin Drive, --, San Diego, CA 92121, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K240208
PMA Number
N/A

All Registered Proprietary Names

ArgenIS JelZir Anterior JelZir ST Multilayer ArgenZ Esthetic Plus ArgenZ Anterior ArgenZ ST+ ArgenZ ST ArgenZ ST Multilayer ArgenZ ST ML ArgenIS ArgenIS ArgenIS ArgenIS 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 ArgenIS JelZir HT+ ArgenZ HT+ JelZir HT+ Multilayer ArgenIS Angled Screw Channel (ASC) Titanium Screws ArgenIS Angled Screw Channel (ASC) Titanium Blanks

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-11
EIH Powder, Porcelain Dental Class 2 872.6660 2016-06-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-12-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-11
EIH Powder, Porcelain Dental Class 2 872.6660 2025-11-25
EIH Powder, Porcelain Dental Class 2 872.6660 2007-10-17
EJH Alloy, Metal, Base Dental Class 2 872.3710 1998-07-16
EIH Powder, Porcelain Dental Class 2 872.6660 2025-11-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-03-11
EIH Powder, Porcelain Dental Class 2 872.6660 2019-04-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-03-17

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
3013551048 The Argen Corporation San Diego, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2433919. Last updated year: 2026. Please use registration number 2433919 when referencing this establishment in official correspondence.
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