FDA device listing

CuRay-Support

FDA device listing 1675740992 · SCIENTIFIC PHARMACEUTICALS, INC.

Key facts

Proprietary names CuRay-Support
Owner/operator SCIENTIFIC PHARMACEUTICALS, INC.
Owner/operator number 2022039
Premarket submissions K832781
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 SCIENTIFIC PHARMACEUTICALS, INC.
Establishment registrations 2022039
FEI numbers 2022039
Establishment operations Contract Manufacturer, 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