BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
FDA Recall #Z-1697-2023 — Class II — May 23, 2023
Product Description
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Reason for Recall
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Recalling Firm
Young Dental Manufacturing I, LLC — Earth City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
344 boxes
Distribution
US distribution to Florida, Nevada, and Pennsylvania.
Code Information
UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated