Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012996495

FEI Number

3012996495

Entity Name

VIARDEN LAB LLC

City/State/Country

Mission, TX, US

Establishment Address

5114 La Homa Rd, Mission, TX 78574, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VIARDEN LAB LLC (Owner Number: 10052806)

Owner / Operator Contact Address

5114 N La Homa Rd, Mission, TX 78574, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PAPER POINT VIARDEN LAB ARTIFICIAL SALIVA VIARDEN LAB LUBRICANT HELYICAINE GEL, HELYICAINE SPRAY ARTICULATION PAPER VIARDEN LAB DESENSITIZER VIARDEN LAB, C-PROTECTOR, VIARCLEAN UP V MINUTE FLUOR GEL, FLUOR FOAM, VIAR VEENER, AQUA FLUOR EUGENOL LIQUID VIARDEN LAB CRI INTERMEDIAL CEMENT VIARDEN LAB, VIAR PACK VIARDEN LAB OZE VIARDEN LAB, OZE TEMPORARY CEMENT PROPHY PASTE VIARDEN LAB, DENT GLOSS, VIARGLOSS INSTABRIGHT VIARDEN LAB C-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTEC FEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINS FEELING DUAL, FEELING CORE, DENT BOND ENDOPREP, ENDOPREP PLUS, DENCAVI, EDTA 17%, VIARZONI-T, FORMOCRESOL VIARDEN LAB PRE-MADE CROWNS ION GLASS ORTHO, ORTHO LUX DT DISCLOSING TABLET VIARDEN LAB, DT DISCLOSING SOLUTION VIARDEN LAB VIARCLEAN WIPES TOTAL DAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2016-10-07
ONK	Oral Lubricant	General Hospital	Class 1	880.6375	2022-02-24
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2020-02-17
EFH	Paper, Articulation	Dental	Class 1	872.6140	2016-10-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-02-17
PME	External Cleaning Solution	Dental	Class 2	872.3260	2020-02-17
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2016-10-07
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2016-10-07
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2020-02-25
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2022-03-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-02-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-04-03
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2020-02-17
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2016-10-07
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2020-02-17
QJC	Plaque Disclosing Agent	Dental	Class 1	872.6855	2020-02-17
PWU	Clean-Up Kit	General Hospital	Class 1	880.6890	2022-04-26
EIE	Dam, Rubber	Dental	Class 1	872.6300	2016-10-07

Official Correspondent

HECTOR PEDROZA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VIARDEN LAB LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3011554142	SHENZHEN DENCO MEDICAL CO., LTD.	Shenzhen Guangdong, CN
2086043	PAC-DENT INC.	Brea, CA, US
2024312	Kerr Corporation	ORANGE, CA, US
3043648115	DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD.	Shijiazhuang Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012996495. Last updated year: 2026. Please use registration number 3012996495 when referencing this establishment in official correspondence.