FDA Medical Device Recalls (openFDA)
Sybron Dental Specialties: Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC 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.
- Recall number
- Z-0989-2012
- Recalling firm
- Sybron Dental Specialties
- Product
- Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC 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.
- Status
- Terminated
- Initiated
- 2011-03-03
- Posted
- 2012-02-11
- Terminated
- 2012-10-05
- Reason
- 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
- 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
- 77,289 Units total
- Distribution
- Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
- Lot, serial or model codes
- All Lots
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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