FDA device listing

Dental prosthesis

FDA device listing 1756237019 · YES DENTAL LAB

Key facts

Proprietary names Dental prosthesis
Owner/operator YES DENTAL LAB
Owner/operator number 10090837
Product codes ELZ
Device names ELZ - Crown, Preformed
Device class Class I
Classification regulations (21 CFR) 872.3330
Review panels Dental
Registered establishments YES DENTAL LAB
Establishment registrations 3031216289
FEI numbers 3031216289
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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