Device recall
Z-1005-2012: Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of…
FDA device recall · Class II · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-1005-2012 |
|---|---|
| Recall event | 59936 |
| Product | Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec… |
| Product code | EBF |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2012 |
| 510(k) numbers | K052106 |
| FEI number | 2024312 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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