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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 K260067
Device Name Eternal Art Porcelain Powders
Applicant
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Applicant Contact Zheng Maggie
Correspondent
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Correspondent Contact Zheng Maggie
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/09/2026
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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