FDA device listing

Upcera Coloring Liquid (I and II)

FDA device listing 1535267567 · Upcera Dental America Inc.

Key facts

Proprietary names Upcera Coloring Liquid (I and II)
Owner/operator Upcera Dental America Inc.
Owner/operator number 10082186
Premarket submissions K141723
Product codes EIH
Device names EIH - Powder, Porcelain
Device class Class II
Classification regulations (21 CFR) 872.6660
Review panels Dental
Registered establishments UPCERA DENTAL AMERICA INC.
Establishment registrations 3019596325
FEI numbers 3019596325
Establishment operations Complaint File Establishment, Repackager/Relabeler
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