FDA device listing

DENTEK WAX

FDA device listing 1951813029 · GDA MARKETING LIMITED

Key facts

Proprietary names DENTEK WAX
Owner/operator GDA MARKETING LIMITED
Owner/operator number 10036203
Product codes EGD
Device names EGD - Wax, Dental, Intraoral
Device class Class I
Classification regulations (21 CFR) 872.6890
Review panels Dental
Registered establishments GDA MARKETING LIMITED
Establishment registrations 3009170513
FEI numbers 3009170513
Establishment operations Foreign Exporter
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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