FDA device listing

SOTA Cloud Smart Sensor

FDA device listing 1058957363 · SOTA Cloud Corporation

Key facts

Proprietary names SOTA Cloud Smart Sensor
Owner/operator SOTA Cloud Corporation
Owner/operator number 10092262
Premarket submissions K251793
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 SOTA CLOUD CORPORATION
Establishment registrations 3034604691
FEI numbers 3034604691
Establishment operations Manufacturer
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