FDA device listing

DESS Ti Base Abutments

FDA device listing 1462567287 · National Dentex LLC

Key facts

Proprietary names DESS Ti Base Abutments
Owner/operator National Dentex LLC
Owner/operator number 9052467
Premarket submissions K222288
Product codes NHA
Device names NHA - Abutment, Implant, Dental, Endosseous
Device class Class II
Classification regulations (21 CFR) 872.3630
Review panels Dental
Registered establishments Group Practice Solutions, NDX Paramount Dental Laboratory, NELSON DENTAL LAB
Establishment registrations 3005512166, 3006473685, 3012690648
FEI numbers 3005512166, 3006473685, 3012690648
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1,000+ 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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