CUSTMBITE Snoring System— 510(k) K221322

Name: FDA 510(k) clearance K221322
Creator: U.S. Food and Drug Administration
Published: 2022-10-27

Substantially Equivalent

Dental Choice Holdings, LLC

FDA 510(k) clearance K221322 for CUSTMBITE Snoring System, Substantially Equivalent on 2022-10-27. Applicant: Dental Choice Holdings, LLC. Device class: 2.

Clearance details

Applicant: Dental Choice Holdings, LLC
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2022-05-06
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRK

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K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)2026-08-27
K261912 — SnØreNegatØr2026-07-31
K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11
K261134 — Dormiva Anti-Snoring Mouth Guard2026-05-14

More clearances from Dental Choice Holdings, LLC

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K183315 — CustMBite Dental Guard2019-08-23

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.