FDA device listing

topmed

FDA device listing 1090517775 · Eytan Import & distribution

Key facts

Proprietary names topmed
Owner/operator Eytan Import & distribution
Owner/operator number 10077532
Product codes KKO
Device names KKO - Ring, Teething, Fluid-Filled
Device class Class II
Classification regulations (21 CFR) 872.5550
Review panels Dental
Registered establishments EYTAN IMPORT & DISTRIBUTION
Establishment registrations 3015268290
FEI numbers 3015268290
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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