Z-0661-2020Class II

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) -

Name: Z-0661-2020 Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) -
Creator: Young Dental Manufacturing Co, LLC
Published: 2019-10-30
License: https://open.fda.gov/license/

Young Dental Manufacturing Co 1, LLC. / initiated 2019-10-30 / Open, Classified / root cause: manufacturing process

FDA source

Young Dental Manufacturing Co, LLC began a recall of Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of... on 2019-10-30. FDA classified it as Class II and gives the reason as "Product shelf life may be shorter than that indicated on the label". 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-0661-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-30
Posted: 2019-12-09
Recalling firm: Young Dental Manufacturing Co 1, LLC.
Product: Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Product code: LBH Varnish, Cavity
Reason for recall: Product shelf life may be shorter than that indicated on the label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification by letter to be made to customer via certified mail. Customers are instructed to return or scrap the affected product. Multiple attempts will be made to contact customers. Returned product will be destroyed. For recall inquiries, contact 224-622-7191.
Quantity in commerce: Batch 84702 - 6500 units; Batch 72766 - 6500 units
Distribution: US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Product codes and lots: Batch 84702; Batch 72766

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0661-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0661-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-09

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)