Z-1006-2012

Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured...

Name: Z-1006-2012 Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured...
Creator: Sybron Dental Specialties
Published: 2010-10-22
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2010-10-22 / Terminated / root cause: manufacturing process

FDA source

Sybron Dental Specialties began a recall of Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is... on 2010-10-22. The reason FDA records is "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". 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-1006-2012
Status: Terminated
Initiated: 2010-10-22
Posted: 2012-02-13
Terminated: 2012-02-13
Recalling firm: Sybron Dental Specialties, Inc.
Product: Flow Tec Part Number 3784-514, 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 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 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: 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 handle the arrangements of a quick return and replacement. Authorized Petron Clinical distributors were asked to identify and recover the affected product lots that may have been shipped to their customers.
Quantity in commerce: 772 units in total
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
Product codes and lots: Syringe Lot Number: 165741 Package Lot Numbers: 167025, 167312, and 168495

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)