Device recall
Z-0661-2020: Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each)…
FDA device recall · Class II · Young Dental Manufacturing Co, LLC
Key facts
| Recall number (Z-number) | Z-0661-2020 |
|---|---|
| Recall event | 84249 |
| 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. |
| Product code | LBH |
| Recalling firm | Young Dental Manufacturing Co, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153334 |
| FEI number | 1941138 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database