510(k) clearance

Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

FDA 510(k) source

510(k) number

K262104

Applicant

Ram.Shaw Pte., Ltd.

Decision date

Aug 27, 2026

Date received

Jun 23, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

LRK

Device type

Device, Anti-Snoring

Device class

Class II

Regulation

21 CFR 872.5570

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Singapore, SG