Z-1697-2023Class II

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Name: Z-1697-2023 BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Creator: Young Dental Manufacturing I, LLC
Published: 2023-05-23
License: https://open.fda.gov/license/

Young Dental Manufacturing Co 1, LLC. / initiated 2023-05-23 / Open, Classified / root cause: manufacturing process

FDA source

Young Dental Manufacturing I, LLC began a recall of BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish on 2023-05-23. FDA classified it as Class II and gives the reason as "The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1697-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-23
Posted: 2023-06-08
Recalling firm: Young Dental Manufacturing Co 1, LLC.
Product: BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Product code: LBH Varnish, Cavity
Reason for recall: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
Root cause tag: manufacturing process
FDA 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 in commerce: 344 boxes
Distribution: US distribution to Florida, Nevada, and Pennsylvania.
Product codes and lots: UDI/DI 00366975000590, Lot number 207540, Exp. 20240930

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08

Product code LBH

K153334Class IIOral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC / cleared 2016-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)