Z-0990-2012

Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514...

Name: Z-0990-2012 Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514...
Creator: Sybron Dental Specialties
Published: 2011-03-03
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2011-03-03 / Terminated / root cause: manufacturing process

FDA source

Sybron Dental Specialties began a recall of 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... on 2011-03-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0990-2012
Status: Terminated
Initiated: 2011-03-03
Posted: 2012-02-11
Terminated: 2012-10-05
Recalling firm: Sybron Dental Specialties, Inc.
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.
Product code: EBF Material, Tooth Shade, Resin
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: All Lots

Product code EBF

K052106Class IISimile FlowPentron Clinical Technologies / cleared 2005-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)