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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K262775
Device Name AquaVance Clear Fluoride Treatment
Applicant
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Daniel Gallegos
Correspondent
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Nikki Huynh
Regulation Number872.3260
Classification Product Code
LBH  
Date Received08/05/2026
Decision Date 10/27/2026
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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