Recall Z-1697-2023 ยท LBH Varnish, Cavity
Young Dental Manufacturing I, LLC
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
| Date | Jun 8, 2023 (initiated May 23, 2023) |
| Status | Open, Classified |
| Reason | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 344 boxes |
| Distribution | US distribution to Florida, Nevada, and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153334 | Oral-B 5% Sodium Fluoride Varnish Young Dental Manufacturing Co. 1, LLC, May 20, 2016 |