FDA-Device2023-06-14Class II

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Young Dental Manufacturing I, LLC
Hazard

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

Sold states
US distribution to Florida, Nevada, and Pennsylvania.
Affected count
344 boxes
Manufactured in
13705 Shoreline Ct E, Earth City, MO, United States
Products
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2023

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