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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
Applicant
Sino-Dentex Co., Ltd.
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Applicant Contact Pengtao Yan
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/21/2023
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
Predetermined Change
Control Plan Authorized		 No
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