FDA device listing

Mirror system

FDA device listing 1084827431 · Seilglobal CO., Ltd

Key facts

Proprietary names Mirror system
Owner/operator Seilglobal CO., Ltd
Owner/operator number 10045865
Product codes EAX
Device names EAX - Mirror, Mouth
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments SEILGLOBAL CO., LTD
Establishment registrations 3007353764
FEI numbers 3007353764
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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