Data / Medical devices / United States / The Argen Corporation

The Argen Corporation: FDA-registered device maker in San Diego, CA, United States, 13 510(k) clearances

Name: The Argen Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Argen Corporation is registered with the FDA (registration 2433919) in San Diego, CA, United States. It lists 7 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 24, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2433919
Address: 5855 Oberlin Dr, San Diego, CA, United States, 92121
Owner or operator: The Argen Corporation (9021799)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: November 24, 1992
Registered through: 2026
Brand names listed: 100-SL, 104-SL, 110-SL, 115-SL, 14 - 437, 14K, 150-SL, 155-SL and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Alloy, Other Noble Metal	EJS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 24, 2024	K242458	ArgenZ MTZ	EIH	Substantially Equivalent	Argen Corporation	accessdata.fda.gov
April 24, 2024	K240208	DESS Dental Smart Solutions	NHA	Substantially Equivalent	Terrats Medical SL	accessdata.fda.gov
November 3, 2020	K201683	PMMA Block	EBG	Substantially Equivalent	Huge Dental Material Co., Ltd.	accessdata.fda.gov
April 12, 2019	K190079	ArgenZ HT+	EIH	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
February 8, 2019	K182833	ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer	EIH	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
May 18, 2018	K172430	ArgenIS Titanium Abutments	NHA	Substantially Equivalent	Argen Corporation	accessdata.fda.gov
August 5, 2016	K160248	ArgenIS Titanium Abutments	NHA	Substantially Equivalent	Argen Corporation	accessdata.fda.gov
September 16, 2015	K143051	ArgenIS Titanium Abutments	NHA	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
July 13, 2015	K150919	ArgenZ Esthetic Plus	EIH	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
July 31, 2014	K140894	ARGEN PMMA	EBG	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
February 17, 2012	K111935	TI-BASE ABUTMENT, 1 CONNECT ABUTMENT	NHA	Substantially Equivalent	Nt-Trading GmbH and CO KG	accessdata.fda.gov
August 15, 2007	K071410	ARGEN PEARL BRAND ZIRCONIA	EIH	Substantially Equivalent	The Argen Corporation	accessdata.fda.gov
September 26, 2000	K002302	SUPER 14	EJH	Substantially Equivalent	Dental Alloy Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.