VIARDEN LAB LLC
Registration 3012996495FEI 3012996495Mission, TX
Owner/operator: VIARDEN LAB LLC
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 23
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 23
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| DYH | ION GLASS ORTHO, ORTHO LUXAdhesive, Bracket And Tooth Conditioner, Resin | Class 2 | 21 CFR 872.3750 | K012673 |
| EMA | FEELING DUAL, FEELING CORE, DENT BONDCement, Dental | Class 2 | 21 CFR 872.3275 | K112574 |
| EMA | PCA CEMENT, IONGLASS, IONGLASS LUXCement, Dental | Class 2 | 21 CFR 872.3275 | — |
| PME | MINUTE FLUOR GEL, FLUOR FOAM, VIAR VEENER, AQUA FLUORExternal Cleaning Solution | Class 2 | 21 CFR 872.3260 | — |
| EJK | CALCIUM HYDROXIDE VIARDEN LAB, HYDROXY PASTE, VIARPEX, VIARBLENDLiner, Cavity, Calcium Hydroxide | Class 2 | 21 CFR 872.3250 | — |
| EBF | FEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINSMaterial, Tooth Shade, Resin | Class 2 | 21 CFR 872.3690 | K001108 |
| EBF | DESENSITIZER VIARDEN LAB, C-PROTECTOR, VIARCLEAN UP VMaterial, Tooth Shade, Resin | Class 2 | 21 CFR 872.3690 | K013970 |
| KIF | ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-RResin, Root Canal Filling | Class 2 | 21 CFR 872.3820 | — |
| EBC | PIT AND FISSURE SEALNT VIARDEN LAB, IONGLASS SEALERSealant, Pit And Fissure, And Conditioner | Class 2 | 21 CFR 872.3765 | K012761 |
| LBH | C-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTECVarnish, Cavity | Class 2 | 21 CFR 872.3260 | — |
| EJR | PROPHY PASTE VIARDEN LAB, DENT GLOSS, VIARGLOSSAgent, Polishing, Abrasive, Oral Cavity | Class 1 | 21 CFR 872.6030 | — |
| PWU | VIARCLEAN WIPESClean-Up Kit | Class 1 | 21 CFR 880.6890 | — |
and 11 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.