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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K252789
Device Name Glass Ceramic
Applicant
Shenzhen Xiangtong Co., Ltd.
Rm. 101,301,701,801,Bldg. 1,#110,Guanchang Rd.
Dalingshan Town
Dongguan,  CN 523800
Applicant Contact Xue Gong
Correspondent
Shenzhen Xiangtong Co., Ltd.
Rm. 101,301,701,801,Bldg. 1,#110,Guanchang Rd.
Dalingshan Town
Dongguan,  CN 523800
Correspondent Contact Xue Gong
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/02/2025
Decision Date 12/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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