FDA Medical Device Recalls (openFDA)
Sybron Dental Specialties: Artiste Flowable Part Number N28A, 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.
- Recall number
- Z-1005-2012
- Recalling firm
- Sybron Dental Specialties
- Product
- Artiste Flowable Part Number N28A, 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.
- Status
- Terminated
- Initiated
- 2010-10-22
- Posted
- 2012-02-13
- Terminated
- 2012-02-13
- Reason
- 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
- 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
- 771 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
- Lot, serial or model codes
- Syringe Lot #165741 Package Lot Numbers: 166023, 167530, and 168445
- 510(k) numbers
- ["K052106"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28