FDA device listing

Duray Intraoral Sensor, Model: DS1; DS2

FDA device listing 2071543686 · Beyes Dental Inc

Key facts

Proprietary names Duray Intraoral Sensor, Model: DS1; DS2
Owner/operator Beyes Dental Inc
Owner/operator number 10034597
Premarket submissions K212279
Product codes MUH
Device names MUH - System, X-Ray, Extraoral Source, Digital
Device class Class II
Classification regulations (21 CFR) 872.1800
Review panels Dental
Registered establishments BEYES DENTAL INC
Establishment registrations 3008770655
FEI numbers 3008770655
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