# FDA recall Z-1697-2023

> **Young Dental Manufacturing I, LLC** · Class II · device recall initiated 2023-05-23.

## Product

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.

## Distribution

US distribution to Florida, Nevada, and Pennsylvania.

## Key facts

- **Recall number:** Z-1697-2023
- **Recalling firm:** Young Dental Manufacturing I, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-23
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Earth City, MO, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1697-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1697-2023. Source: US FDA. Licensed CC0.

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