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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 K262280
Device Name Mouth guard
Applicant
Dongguan Yiyao Science & Technology Development Co., Ltd.
Rm. 501, #11 Shennan Yiheng St., Shenxiang, Qishi Town
Dongguan,  CN
Applicant Contact Xianzhao Tang
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Classification Product Code
OBR  
Date Received07/06/2026
Decision Date 10/26/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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