FDA device listing

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA device listing 1449838856 · Zelia Dental Lab LLC

Key facts

Owner/operator Zelia Dental Lab LLC
Owner/operator number 10091536
Product codes NOF
Device names NOF - System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Device class Class II
Classification regulations (21 CFR) 872.3661
Review panels Dental
Registered establishments ZELIA DENTAL LAB LLC
Establishment registrations 3032850585
FEI numbers 3032850585
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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