FDA device listing

NEXUS 3

FDA device listing 1328683200 · Jersey Dental Supplies

Key facts

Proprietary names NEXUS 3
Owner/operator Jersey Dental Supplies
Owner/operator number 10050503
Premarket submissions K062519
Product codes EMA
Device names EMA - Cement, Dental
Device class Class II
Classification regulations (21 CFR) 872.3275
Review panels Dental
Registered establishments JERSEY DENTAL SUPPLIES
Establishment registrations 3012187973
FEI numbers 3012187973
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

Browse all FDA device listings