The Panthera Anti-Snoring Device— 510(k) K143244

Name: FDA 510(k) clearance K143244
Creator: U.S. Food and Drug Administration
Published: 2014-12-15

Substantially Equivalent

Panthera Dental, Inc.

FDA 510(k) clearance K143244 for The Panthera Anti-Snoring Device, Substantially Equivalent on 2014-12-15. Applicant: Panthera Dental, Inc.. Device class: 2.

Clearance details

Applicant: Panthera Dental, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2014-11-12
Decision date: 2014-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec City, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRK

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K261912 — SnØreNegatØr2026-07-31
K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11
K261134 — Dormiva Anti-Snoring Mouth Guard2026-05-14

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K203596 — Panthera Occlusal Appliance2021-04-20
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K183580 — Panthera Dental Milled Bars2019-06-20
K171576 — The Panthera Anti-Snoring X3 Device2018-02-22
K173466 — Panthera Dental Milled Bars2018-01-26

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.