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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 K250811
Device Name Dental Zirconia Ceramic
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Jeffry Ye
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/17/2025
Decision Date 04/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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