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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 K200462
Device Name EtchPro Etching Gel
Applicant
Belport Company, Inc., Gingi-Pak
4825 Calle Alto,
Camarillo,  CA  93012
Applicant Contact Daniel Wang
Correspondent
Belport Company, Inc., Gingi-Pak
4825 Calle Alto,
Camarillo,  CA  93012
Correspondent Contact Daisy Ni
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/25/2020
Decision Date 09/02/2020
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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