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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K262104
Device Name Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
Applicant
Ram.Shaw Pte., Ltd.
120 Robinson Rd., #13-01, Singapore 068913
Singapore,  SG 068913
Applicant Contact Emma Chen
Correspondent
Ram.Shaw Pte. , Ltd.
120 Robinson Rd., #13-01, Singapore 068913
Singapore,  SG 068913
Correspondent Contact Emma Chen
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received06/23/2026
Decision Date 08/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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