Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)— 510(k) K253845

Substantially Equivalent

Ram.Shaw Pte. , Ltd.

FDA 510(k) clearance K253845 for Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB), Substantially Equivalent on 2026-03-03. Applicant: Ram.Shaw Pte. , Ltd..

Clearance details

Applicant: Ram.Shaw Pte. , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2025-12-02
Decision date: 2026-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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.