Device product
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Z-1697-2023
Product summary
- Event
- Event 92401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 344 boxes
- Official record key
device-enforcement:Z-1697-2023
Official wording
Reason: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Code information: UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
Distribution pattern: US distribution to Florida, Nevada, and Pennsylvania.
Derived failure modes
-
Unknown
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.