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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 K253845
Device Name Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
Applicant
Ram.Shaw Pte. , Ltd.
112 Robinson Rd. # 03-01 Robinson 112, Singapore
Singapore,  SG 068902
Applicant Contact Emma Chen
Correspondent
Ram.Shaw Pte. , Ltd.
112 Robinson Rd. # 03-01 Robinson 112, Singapore
Singapore,  SG 068902
Correspondent Contact Emma Chen
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/02/2025
Decision Date 03/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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