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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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