Recall Z-1005-2012 ยท EBF Material, Tooth Shade, Resin
Sybron Dental Specialties
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 (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain rep
| Date | Feb 13, 2012 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. |
| Root cause | Nonconforming Material/Component |
| Action | Sybron Dental sent a Recall Letter dated November 15, 2010 to consignees informing them of the above mentioned public reason for recall and asking them to determine if they have any affected products in their inventory and requesting their cooperation in returning any affected product which they still have in their stock. Product was to be returned and replaced at no charge. They also requested that consignees complete and fax back an enclosed return from , whether or not they had any product to return. Consignees were told to call Pentron Customer Service at (800) 551-0283 directly to hand |
| Quantity | 771 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052106 | SIMILE FLOW Pentron Clinical Technologies, Oct 31, 2005 |