Cleared Traditional

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)

K253845 · Ram.Shaw Pte. , Ltd. · Dental

Mar 2026

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K253845 is an FDA 510(k) clearance for the Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB), a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Ram.Shaw Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 3, 2026, 91 days after receiving the submission on December 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K253845 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2025
Decision Date	March 03, 2026
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF