FDA device listing

MARK3® Saliva Ejectors,MARK3® Surgical Aspirating Tips

FDA device listing 1286633840 · CARGUS International Inc.

Key facts

Proprietary names MARK3® Saliva Ejectors,MARK3® Surgical Aspirating Tips
Owner/operator CARGUS International Inc.
Owner/operator number 9033437
Product codes DYN
Device names DYN - Mouthpiece, Saliva Ejector
Device class Class I
Classification regulations (21 CFR) 872.6640
Review panels Dental
Registered establishments CARGUS INT'L, INC.
Establishment registrations 2437780
FEI numbers 3001746544
Establishment operations Repackager/Relabeler
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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