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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K262559
Device Name Mouth Guard
Applicant
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
Rm.703, 7/F, Bldg. E7, Phase Ii, Cec Software Park, # 18 Jia
Dongfanghong St., Hi-Tech Development Zone
Changsha,  CN 410000
Applicant Contact Wei Luo
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Classification Product Code
OBR  
Date Received07/24/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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