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U.S. Department of Health and Human Services

Class 2 Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)

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 Class 2 Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)see related information
Date Initiated by FirmMarch 03, 2011
Date PostedFebruary 11, 2012
Recall Status1 Terminated 3 on October 05, 2012
Recall NumberZ-0989-2012
Recall Event ID 60693
510(K)NumberK052106 
Product Classification Material, tooth shade, resin - Product Code EBF
ProductArtiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this 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 Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
Code Information All Lots 
FEI Number 2024312
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall		The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPentron Clinical sent an initial "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and fax back an enclosed recall return form in order to confirm their receipt of the recall notification. A second "URGENT: MEDICAL DEVICE RECALL" letter dated November 10, 2011 was sent to all affected customers because Pentron Clinical expanded the recall. On December 8, 2011 another recall communication was forwarded to all affected customers to change the wording on the letter to make it more clear to the customers about the recall expansion. Contact Pentron Clinical Customer Service at 1-800-551-0283 for questions regarding this recall.
Quantity in Commerce77,289 Units total
DistributionWorldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = EBF
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