FDA device listing

VITA SUPRINITY

FDA device listing 2057600457 · VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

Key facts

Proprietary names VITA SUPRINITY
Owner/operator VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
Owner/operator number 9052908
Premarket submissions K132070
Product codes EIH
Device names EIH - Powder, Porcelain
Device class Class II
Classification regulations (21 CFR) 872.6660
Review panels Dental
Registered establishments VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
Establishment registrations 1000625496
FEI numbers 4838
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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