BencoDental iris 5% NaF varnish — Class II medical device recall Z-1697-2023
Ongoing recall by Young Dental Manufacturing I, LLC, reported 2023-06-14, distributed in FL, NV, PA. The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
| Recall number | Z-1697-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Young Dental Manufacturing I, LLC, Earth City, MO, United States |
| Recall initiated | 2023-05-23 |
| Classified | 2023-06-08 |
| Reported by FDA | 2023-06-14 |
| Distributed | FL, NV, PA |
| Quantity | 344 boxes |
| UPC / GTIN / UDI-DI | 00366975000590 |
| Lot numbers | 20240930, 207540 |
| Model numbers | 4323-635 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1697-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.