Z-2259-2013Class II

NX3 Try-In Gel. The product is used as a tooth shade resin material

Name: Z-2259-2013 NX3 Try-In Gel. The product is used as a tooth shade resin material
Creator: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Published: 2013-09-13
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2013-09-13 / Terminated / root cause: labeling and UDI

FDA source

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical began a recall of NX3 Try-In Gel. The product is used as a tooth shade resin material on 2013-09-13. FDA classified it as Class II and gives the reason as "Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2259-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Posted: 2013-09-19
Terminated: 2014-02-11
Recalling firm: Sybron Dental Specialties, Inc.
Product: NX3 Try-In Gel. The product is used as a tooth shade resin material.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Kerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.
Quantity in commerce: 197 units
Distribution: Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.
Product codes and lots: Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2259-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2259-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-19

Product code EBF

K001899Class IIImproved Try-in GelSybron Dental Specialties, Inc. / cleared 2000-08-28

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)