FDA device listing

3Delta Etemp,P pro Crown & Bridge

FDA device listing 1093177318 · DELTAMED GMBH

Key facts

Proprietary names 3Delta Etemp,P pro Crown & Bridge
Owner/operator DELTAMED GMBH
Owner/operator number 9026386
Premarket submissions K200039
Product codes EBG
Device names EBG - Crown And Bridge, Temporary, Resin
Device class Class II
Classification regulations (21 CFR) 872.3770
Review panels Dental
Registered establishments DELTAMED GMBH
Establishment registrations 3002789526
FEI numbers 3002789526
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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