510(k) K262775
K262775 is an FDA 510(k) premarket notification submitted by The Belport Company Inc., DBA Gingi-Pak for the device "AquaVance Clear Fluoride Treatment". The FDA issued a decision of Substantially Equivalent on Oct 27, 2026. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. The Belport Company Inc., DBA Gingi-Pak has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2026
- Date Received
- Aug 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
- 510(k)