FDA device listing

Wax, Dental, Intraoral

FDA device listing 1141014032 · CALIBAJA MANUFACTURING, S.A. DE C.V.

Key facts

Owner/operator CALIBAJA MANUFACTURING, S.A. DE C.V.
Owner/operator number 9049944
Product codes EGD
Device names EGD - Wax, Dental, Intraoral
Device class Class I
Classification regulations (21 CFR) 872.6890
Review panels Dental
Registered establishments CALIBAJA MANUFACTURING, S.A. DE C.V.
Establishment registrations 3003678542
FEI numbers 3003678542
Establishment operations Contract 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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