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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 K221450
Device Name Phosphoric Acid Etching Gel
Applicant
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao City,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao City,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/18/2022
Decision Date 09/12/2022
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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