FDA device listing

IPS CEREC BLOCKS

FDA device listing 1008868201 · SAMTRADE SUPPLIES INC.

Key facts

Proprietary names IPS CEREC BLOCKS
Owner/operator SAMTRADE SUPPLIES INC.
Owner/operator number 10056140
Premarket submissions K051705
Product codes EIH
Device names EIH - Powder, Porcelain
Device class Class II
Classification regulations (21 CFR) 872.6660
Review panels Dental
Registered establishments SAMTRADE SUPPLIES INC.
Establishment registrations 3008912871
FEI numbers 3008912871
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 10–99 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