FDA device listing

Apex Locater

FDA device listing 1992045226 · Enova Illumination Inc.

Key facts

Proprietary names Apex Locater
Owner/operator Enova Illumination Inc.
Owner/operator number 2127132
Premarket submissions K181087
Product codes LQY
Device names LQY - Locator, Root Apex
Device class Unclassified
Classification regulations (21 CFR) ORCA1.LQY
Review panels Dental
Registered establishments ENOVA ILLUMINATION, INC
Establishment registrations 2127132
FEI numbers 2127132
Establishment operations Complaint File Establishment
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

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