FDA device listing

Film, Radiographic

FDA device listing 1252201753 · DENTAMERICA

Key facts

Owner/operator DENTAMERICA
Owner/operator number 2024949
Product codes IWZ
Device names IWZ - Film, Radiographic
Device class Class I
Classification regulations (21 CFR) 892.1840
Review panels Radiology
Registered establishments DENTAMERICA
Establishment registrations 2024949
FEI numbers 2024949
Establishment operations Repackager/Relabeler
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