Device 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.
Z-0661-2020
Product summary
- Event
- Event 84249
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Batch 84702 - 6500 units; Batch 72766 - 6500 units
- Official record key
device-enforcement:Z-0661-2020
Official wording
Reason: Product shelf life may be shorter than that indicated on the label.
Code information: Batch 84702; Batch 72766
Distribution pattern: US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Derived failure modes
-
Unknown
Product shelf life may be shorter than that indicated on the label.