FDA device listing

FG Dental Burs

FDA device listing 1061909507 · Bioline Dental Implant Systems Ltd

Key facts

Proprietary names FG Dental Burs
Owner/operator Bioline Dental Implant Systems Ltd
Owner/operator number 10092547
Product codes EJL
Device names EJL - Bur, Dental
Device class Class I
Classification regulations (21 CFR) 872.3240
Review panels Dental
Registered establishments BIOLINE DENTAL IMPLANT SYSTEMS LTD
Establishment registrations 3014329459
FEI numbers 3014329459
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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