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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 K201787
Device Name Light Cure Dental Adhesive
Applicant
Rizhao HuGe Biomaterials Company, Ltd.
No.2 North Zhaoyang Road, District of Donggang
Rizhao City,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Rizhao HuGe Biomaterials Company, Ltd.
No.2 North Zhaoyang Road, District of Donggang
Rizhao City,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/30/2020
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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