FDA device listing

Panthera Anti-Snoring X3 Device

FDA device listing 1739424705 · Panthera Dental Inc.

Key facts

Proprietary names Panthera Anti-Snoring X3 Device
Owner/operator Panthera Dental Inc.
Owner/operator number 10042081
Premarket submissions K171576
Product codes LRK
Device names LRK - Device, Anti-Snoring
Device class Class II
Classification regulations (21 CFR) 872.5570
Review panels Dental
Registered establishments PANTHERA DENTAL INC
Establishment registrations 3009779268
FEI numbers 3009779268
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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