FDA device listing

Alien HT,Alien Multi-Layer

FDA device listing 1619871567 · Alien Milling Technologies

Key facts

Proprietary names Alien HT,Alien Multi-Layer
Owner/operator Alien Milling Technologies
Owner/operator number 10055155
Premarket submissions K141724
Product codes EIH
Device names EIH - Powder, Porcelain
Device class Class II
Classification regulations (21 CFR) 872.6660
Review panels Dental
Registered establishments ALIEN MILLING TECHNOLOGIES
Establishment registrations 3013376795
FEI numbers 3013376795
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

Browse all FDA device listings