Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)— 510(k) K262104

Name: FDA 510(k) clearance K262104
Creator: U.S. Food and Drug Administration
Published: 2026-08-27

Substantially Equivalent

Ram.Shaw Pte., Ltd.

FDA 510(k) clearance K262104 for Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT), Substantially Equivalent on 2026-08-27. Applicant: Ram.Shaw Pte., Ltd.. Device class: 2.

Clearance details

Applicant: Ram.Shaw Pte., Ltd.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2026-06-23
Decision date: 2026-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRK

view all

K261912 — SnØreNegatØr2026-07-31
K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11
K261134 — Dormiva Anti-Snoring Mouth Guard2026-05-14
K252942 — ShaeferH2026-04-10

More clearances from Ram.Shaw Pte., Ltd.

view all

K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)2026-03-03

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.