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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 K232978
Device Name DX. Bond V Dental Bonding Adhesive
Sino-Dentex Co., Ltd.
1000 Westgate Drive Suite #510k
Saint Paul,  MN  55114
Applicant Contact Pengtao Yan
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3200
Classification Product Code
Date Received09/21/2022
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No