FDA device listing

LUMIGrip

FDA device listing 1680738325 · DEN-MAT HOLDINGS, LLC

Key facts

Proprietary names LUMIGrip
Owner/operator DEN-MAT HOLDINGS, LLC
Owner/operator number 2018957
Product codes JEX
Device names JEX - Plier, Orthodontic
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments DEN-MAT HOLDINGS, LLC
Establishment registrations 2018957
FEI numbers 2018957
Establishment operations Complaint File Establishment, 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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