FDA device listing

FEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINS

FDA device listing 1988364977 · VIARDEN LAB LLC

Key facts

Proprietary names FEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINS
Owner/operator VIARDEN LAB LLC
Owner/operator number 10052806
Premarket submissions K001108
Product codes EBF
Device names EBF - Material, Tooth Shade, Resin
Device class Class II
Classification regulations (21 CFR) 872.3690
Review panels Dental
Registered establishments VIARDEN LAB LLC
Establishment registrations 3012996495
FEI numbers 3012996495
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings