FDA device listing

Root Canal Spreader

FDA device listing 1749809170 · ACCOMPANY SURGICAL

Key facts

Proprietary names Root Canal Spreader
Owner/operator ACCOMPANY SURGICAL
Owner/operator number 8041151
Product codes EKQ
Device names EKQ - Preparer, Root Canal Endodontic
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments ACCOMPANY SURGICAL
Establishment registrations 8041151
FEI numbers 3006037906
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

Browse all FDA device listings