Class 2 Device Recall OralB Practitioner Series

• Date Initiated by Firm: October 30, 2019
• Create Date: December 09, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0661-2020
• Recall Event ID: 84249
• 510(K)Number: K153334
• Product Classification: Varnish, cavity - Product Code LBH
• 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.
• Code Information: Batch 84702; Batch 72766
• FEI Number: 1941138
• Recalling Firm/ Manufacturer: Young Dental Manufacturing Co, LLC; 13705 Shoreline Ct E; Earth City MO 63045-1202
• For Additional Information Contact: Jose Espino; 224-622-7191
• Manufacturer Reason for Recall: Product shelf life may be shorter than that indicated on the label.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LBH