BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635 recallZ-1697-2023 · Young Dental Manufacturing I, LLC · initiated May 23, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Young Dental Manufacturing I, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
FDA root cause category: Employee error
What the company is doing
Young Dental notified the single customer via certified mail on 05/23/2023. The customer was instructed to discard or return the affected product and complete and return the response form.
Recall details
- Recall number
- Z-1697-2023
- Status
- Open, Classified
- Initiated by the company
- May 23, 2023
- Posted by the FDA
- Jun 8, 2023
- Recalling firm
- Young Dental Manufacturing I, LLC
- Quantity
- 344 boxes
- Product code
- LBH
- FDA submissions
- K153334
- Distribution
- US distribution to Florida, Nevada, and Pennsylvania.
Product description
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Code information (models, lots, serial numbers)
UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IRIS 4323-635Benco Dental Supply CO. · Varnish, Cavity1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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