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Parker Quality & Compliance

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510(k) clearance

AquaVance Clear Fluoride Treatment

FDA 510(k) source

510(k) number
K262775
Applicant
The Belport Company Inc., DBA Gingi-Pak
Decision date
Oct 27, 2026
Date received
Aug 5, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
LBH
Device type
Varnish, Cavity
Device class
Class II
Regulation
21 CFR 872.3260
Advisory committee
Dental
Statement or summary
Summary
Third party
N
Location
Camarillo, CA, US