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Open, Classified

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

FDA Recall Z-1697-2023 · Posted 2023-06-08

Recalling FirmYoung Dental Manufacturing I, LLC
Recall StatusOpen, Classified
Product CodeLBH
Date Initiated2023-05-23
Product Quantity344 boxes

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

US distribution to Florida, Nevada, and Pennsylvania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153334Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC · 2016-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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