FDA device listing

Straumann Cementable Abutments

FDA device listing 1477977496 · Digital Age Dental Laboratories, Ltd.

Key facts

Proprietary names Straumann Cementable Abutments
Owner/operator Digital Age Dental Laboratories, Ltd.
Owner/operator number 10028093
Premarket submissions K203355
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 Digital Age Dental Laboratories, Ltd.
Establishment registrations 3007597023
FEI numbers 3007597023
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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