FDA device listing

Pegasus Dental Alloy

FDA device listing 1462495292 · Sterngold

Key facts

Proprietary names Pegasus Dental Alloy
Owner/operator Sterngold
Owner/operator number 10023675
Premarket submissions K962302
Product codes EJT
Device names EJT - Alloy, Gold-Based Noble Metal
Device class Class II
Classification regulations (21 CFR) 872.3060
Review panels Dental
Registered establishments Sterngold Dental LLC
Establishment registrations 2921595
FEI numbers 2921595
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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