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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K242530
Device Name HF-Etchant Hydrofluoric Acid Etching Gel
Applicant
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Codes
EIH   PME  
Date Received08/26/2024
Decision Date 12/20/2024
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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