FDA device listing

Bur, Dental

FDA device listing 1366302539 · STRYKER CORP.

Key facts

Owner/operator STRYKER CORP.
Owner/operator number 1811755
Product codes EJL
Device names EJL - Bur, Dental
Device class Class I
Classification regulations (21 CFR) 872.3240
Review panels Dental
Registered establishments Stryker Instruments, STRYKER IRELAND LTD., INSTRUMENTS DIVISION, Stryker Ireland Ltd. Instruments Division, Innovation Centre
Establishment registrations 9616696, 3015967359, 3040335671
FEI numbers 3003164255, 3015967359, 3040335671
Establishment operations Complaint File Establishment, Specification Developer, 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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