FDA device listing

Excavator

FDA device listing 1681395045 · Acme Commercial Ways Ltd.

Key facts

Proprietary names Excavator
Owner/operator Acme Commercial Ways Ltd.
Owner/operator number 10095260
Product codes EKC
Device names EKC - Excavator, Dental, Operative
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments ACME COMMERCIAL WAYS LTD.
Establishment registrations 3008797953
FEI numbers 3008797953
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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