FDA Registration
Active
🇺🇸 United States
VIARDEN LAB LLC
Reg #: 3012996495
·
FEI: 3012996495
·
Expires 2026
Products
21
Proprietary Names
25
Establishment Types
3
Classifications
21
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Registration Details
- Registration Name
- VIARDEN LAB LLC
- Registration Number
- 3012996495
- FEI Number
- 3012996495
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5114 La Homa Rd
- City
- Mission
- State
- TX
- ZIP
- 78574
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013970
Owner / Operator
- Firm Name
- VIARDEN LAB LLC
- Operator Number
- 10052806
- Address
- 5114 N La Homa Rd
- City
- Mission
- State
- TX
- Postal Code
- 78574
- Country
- US
- Correspondent
- HECTOR J PEDROZA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2016-10-07 |
| Oral Lubricant | ONK | Class 1 | General Hospital | No | 2022-02-24 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2020-02-17 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2016-10-07 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2020-02-17 |
| External Cleaning Solution | PME | Class 2 | Dental | No | 2020-02-17 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2016-10-07 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2016-10-07 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2020-02-25 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2022-03-02 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2017-04-03 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2020-02-17 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2016-10-07 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2020-02-17 |
| Plaque Disclosing Agent | QJC | Class 1 | Dental | No | 2020-02-17 |
| Clean-Up Kit | PWU | Class 1 | General Hospital | No | 2022-04-26 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2016-10-07 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2020-02-17 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2016-10-07 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2020-02-17 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2020-02-17 |
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
ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-R
VIARDEN LAB GUTTAPERCHA POINTS, VIARDEN LAB PELLETS
PIT AND FISSURE SEALNT VIARDEN LAB, IONGLASS SEALER
PCA CEMENT, IONGLASS, IONGLASS LUX
CALCIUM HYDROXIDE VIARDEN LAB, HYDROXY PASTE, VIARPEX, VIARBLEND
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device