Recall Z-1697-2023— Young Dental Manufacturing I, LLC

Name: FDA recall Z-1697-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-23

Class II · Ongoing

Class II FDA medical device recall by Young Dental Manufacturing I, LLC, initiated 2023-05-23. It names one FDA 510(k) clearance: K153334. Product: BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish. Reason: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum..

Recalling firm: Young Dental Manufacturing I, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-23
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

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

Reason for recall

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

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