Z-0455-2012

Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and

Name: Z-0455-2012 Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and
Creator: Kerr Corporation
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

Kerr Corporation began a recall of Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal... on 2011-03-03. The reason FDA records is "The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product". 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-0455-2012
Status: Terminated
Initiated: 2011-03-03
Posted: 2012-01-11
Terminated: 2012-01-09
Recalling firm: Sybron Dental Specialties, Inc.
Product: Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.
Product code: EMA Cement, Dental
Reason for recall: The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pentron Clinical sent an URGENT: Medical Device Recall letter dated April 20, 2011 to all affected customers. The letter described the product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all product(s) subject to recall for return and exchange at no charge. In addition, the letter states that if the product was further distributed to contact their customers and notify them of the recall. Customers were also asked to complete and return the enclosed Recall Return Form. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangement of a quick return and replacement.
Quantity in commerce: 100 Units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Armenia, Russia and Ukraine.
Product codes and lots: Part Number: N36TB, Lot/Serial Number: 3416180

Product code EMA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)