FDA device listing

Tooth Shade Resin Material

FDA device listing 1066919784 · UFP Technologies, Inc.

Key facts

Proprietary names Tooth Shade Resin Material
Owner/operator UFP Technologies, Inc.
Owner/operator number 10031344
Product codes EBF, EBG, EBI
Device names EBF - Material, Tooth Shade, Resin, EBG - Crown And Bridge, Temporary, Resin, EBI - Resin, Denture, Relining, Repairing, Rebasing
Device class Class II
Classification regulations (21 CFR) 872.3690, 872.3760, 872.3770
Review panels Dental
Registered establishments CONTECH MEDICAL, INC.
Establishment registrations 1221541
FEI numbers 1221541
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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