FDA device listing

Matrix Gripper,spotOn

FDA device listing 1696041622 · ArtCraft Dental, Inc.

Key facts

Proprietary names Matrix Gripper,spotOn
Owner/operator ArtCraft Dental, Inc.
Owner/operator number 10060147
Product codes EJB
Device names EJB - Handle, Instrument, Dental
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments ARTCRAFT DENTAL, INC.
Establishment registrations 3015422158
FEI numbers 3015422158
Establishment operations Repackager/Relabeler
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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