Manufacturer registered with FDA
Viarden Lab LLC
Mission, TX, United States. Lists 18 dental device types with FDA across 1 registered establishment.
- Device types listed
- 18
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Viarden Lab LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | DESENSITIZER VIARDEN LAB, C-PROTECTOR, VIARCLEAN UP VFEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINS | 2020 |
| Dental CementEMA · Class 2 | Dental cements | Maker | FEELING DUAL, FEELING CORE, DENT BONDPCA CEMENT, IONGLASS, IONGLASS LUX | 2017 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | ION GLASS ORTHO, ORTHO LUX | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | PIT AND FISSURE SEALNT VIARDEN LAB, IONGLASS SEALER | 2020 |
| Articulation PaperEFH · Class 1 | — | Lister | ARTICULATION PAPER VIARDEN LAB | 2016 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | TOTAL DAM | 2016 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | CALCIUM HYDROXIDE VIARDEN LAB, HYDROXY PASTE, VIARPEX, VIARBLEND | 2020 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | PROPHY PASTE VIARDEN LAB, DENT GLOSS, VIARGLOSS | 2016 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | VIARDEN LAB GUTTAPERCHA POINTS, VIARDEN LAB PELLETS | 2016 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | PAPER POINT VIARDEN LAB | 2016 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | ENDOPREP, ENDOPREP PLUS, DENCAVI, EDTA 17%, VIARZONI-T, FORMOCRESOL | 2020 |
| Preformed CrownELZ · Class 1 | — | Maker | VIARDEN LAB PRE-MADE CROWNS | 2016 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | CRI INTERMEDIAL CEMENT VIARDEN LAB, VIAR PACK VIARDEN LABEUGENOL LIQUID VIARDEN LABOZE VIARDEN LAB, OZE TEMPORARY CEMENT | 2016 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-R | 2020 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | C-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTEC | 2022 |
| Dental Stain EraserMAU · Class 1 | — | Maker | INSTABRIGHT VIARDEN LAB | 2020 |
| External Cleaning SolutionPME · Class 2 | — | Maker | MINUTE FLUOR GEL, FLUOR FOAM, VIAR VEENER, AQUA FLUOR | 2020 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | DT DISCLOSING TABLET VIARDEN LAB, DT DISCLOSING SOLUTION VIARDEN LAB | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Viarden Lab LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Prime Dental Manufacturing, Inc. (5).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Jan 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. | EMA Dental Cement |
| 19 Feb 2002 | K013970 | PRIME-DENT HEMA DESENSITIZER | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 30 May 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VIARDEN LAB LLCFDA reg. 3012996495 | Mission, TX, United States | Manufacturer for export, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052806). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.