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Terminated

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.

FDA Recall Z-0990-2012 · Posted 2012-02-11

Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeEBF
Date Initiated2011-03-03
Date Terminated2012-10-05
Product Quantity77,289 Units total

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052106SIMILE FLOWPentron Clinical Technologies · 2005-10-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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