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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, prescription
510(k) Number K230592
Device Name LuxCreo Dental Night Guard Resin
Applicant
LuxCreo Inc.
940 Old County Road
Belmont,  CA  94002
Applicant Contact Mike Yang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 1407, Jingting Building, Dongzhou Community
Guangming Street, Guangming District
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received03/03/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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