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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 K262756
Device Name Zirconia Dental Ceramics and Staining Solution
Applicant
Fanen New Materials Technology (Suzhou) Co., Ltd.
3rd Floor, Rm. 7, Bldg. 029, # 173 Pengxi S. Rd., Kunshan De
Suzhou,  CN 215300
Applicant Contact Haibo Yi
Correspondent
ABMED MEDICAL TECHNOLOGY PTY , Ltd.
48/6 Herbert St.
St Leonards,  AU NSW 2065
Correspondent Contact Boyle Wang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/03/2026
Decision Date 10/29/2026
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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