FDA Medical Device Recalls (openFDA)
Young Dental Manufacturing I, LLC: BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
- Recall number
- Z-1697-2023
- Recalling firm
- Young Dental Manufacturing I, LLC
- Product
- BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
- Status
- Open, Classified
- Initiated
- 2023-05-23
- Posted
- 2023-06-08
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 00366975000590, Lot number 207540, Exp. 20240930
- 510(k) numbers
- K153334
- PMA numbers
- not on file
- Product code
- LBH
- Firm FEI
- 1941138
- Firm city
- Earth City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28