FDA device listing

DIGITAL SENSOR SHEATH,FLEX-BITE TAB,INTRA ORAL CAMERA SHEATHS,PHOSPHOR PLATE PROTECTOR

FDA device listing 1204429571 · Tornado Plastics

Key facts

Proprietary names DIGITAL SENSOR SHEATH,FLEX-BITE TAB,INTRA ORAL CAMERA SHEATHS,PHOSPHOR PLATE PROTECTOR
Owner/operator Tornado Plastics
Owner/operator number 10037365
Product codes EGZ
Device names EGZ - Holder, Film, X-Ray
Device class Class I
Classification regulations (21 CFR) 872.1905
Review panels Dental
Registered establishments TORNADO PLASTICS
Establishment registrations 3003000761
FEI numbers 3003000761
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

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