Recall Z-0661-2020— Young Dental Manufacturing Co, LLC

Name: FDA recall Z-0661-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-30

Class II · Ongoing

Class II FDA medical device recall by Young Dental Manufacturing Co, LLC, initiated 2019-10-30. It names one FDA 510(k) clearance: K153334. 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.. Reason: Product shelf life may be shorter than that indicated on the label..

Recalling firm: Young Dental Manufacturing Co, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-10-30
Firm location: Earth City, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K153334 — Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC·cleared 2016-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Product shelf life may be shorter than that indicated on the label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.