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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 K251628
Device Name Mandibular Advancement Device L07
Applicant
Dcstar, Inc.
228 Park Ave. S 30327
New York,  NY  10003
Applicant Contact Leo Liu
Correspondent
Dcstar, Inc.
228 Park Ave. S 30327
New York,  NY  10003
Correspondent Contact Emma Chen
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received05/28/2025
Decision Date 10/22/2025
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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