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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 Firm March 03, 2011
Date Posted February 11, 2012
Recall Status1 Terminated 3 on October 05, 2012
Recall Number Z-0990-2012
Recall Event ID 60693
510(K)Number K052106  
Product Classification Material, tooth shade, resin - Product Code EBF
Product Flow Tec Nano-Hybrid Flowable Affected Product

Syringe Part No. Value Pack Part. No. Shade
BEN3784-514 BEN3786-754 A1
BEN3784-532 BEN3786-763 A2
BEN3784-541 BEN3784-738 A3
BEN3784-550 BEN3784-747 A3.5
BEN3784-569 BEN3784-756 A4
BEN3784-578 BEN3784-765 B1
BEN3784-596 BEN3784-774 B2
BEN3784-603 BEN3784-783 C1
BEN3784-612 BEN3784-792 C2
BEN3784-621 BEN3784-809 C3
BEN3784-649 BEN3784-818 D2
BEN3784-722 BEN3784-818 Universal Opaque
BEN3784-685 BEN3784-827 A0
BEN3784-701 BEN3784-836 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
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
Action Pentron 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 Commerce 77,289 Units total
Distribution Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = EBF and Original Applicant = PENTRON CLINICAL TECHNOLOGIES
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