Data / Medical devices / United States / Viarden Lab LLC

Viarden Lab LLC: FDA-registered device maker in Mission, TX, United States, 5 510(k) clearances

Name: Viarden Lab LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Viarden Lab LLC is registered with the FDA (registration 3012996495) in Mission, TX, United States. It lists 21 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 23, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012996495
Address: 5114 La Homa Rd, Mission, TX, United States, 78574
Owner or operator: VIARDEN LAB LLC (10052806)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: October 7, 2016
Registered through: 2026
Brand names listed: ARTICULATION PAPER VIARDEN LAB, ARTIFICIAL SALIVA VIARDEN LAB LUBRICANT, C-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTEC, CALCIUM HYDROXIDE VIARDEN LAB, HYDROXY PASTE, VIARPEX, VIARBLEND, CRI INTERMEDIAL CEMENT VIARDEN LAB, VIAR PACK VIARDEN LAB, DESENSITIZER VIARDEN LAB, C-PROTECTOR, VIARCLEAN UP V, DT DISCLOSING TABLET VIARDEN LAB, DT DISCLOSING SOLUTION VIARDEN LAB, ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-R and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Clean-Up Kit	PWU	1	Manufacturer for export	accessdata.fda.gov
Crown, Preformed	ELZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Manufacturer	accessdata.fda.gov
External Cleaning Solution	PME	2	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Manufacturer for export	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Oral Lubricant	ONK	1	Manufacturer for export	accessdata.fda.gov
Paper, Articulation	EFH	1	Repackager or relabeler	accessdata.fda.gov
Plaque Disclosing Agent	QJC	1	Manufacturer	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Manufacturer for export	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Repackager or relabeler	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Manufacturer	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
January 23, 2012	K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	EMA	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
February 19, 2002	K013970	PRIME-DENT HEMA DESENSITIZER	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 1, 2001	K012761	PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT	EBC	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
October 24, 2001	K012673	PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM	DYH	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
May 30, 2000	K001108	PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 23, 2012. 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.