Recall Z-2259-2013— Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Name: FDA recall Z-2259-2013
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Class II · Terminated

Class II FDA medical device recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, initiated 2013-09-13, terminated 2014-02-11. It names one FDA 510(k) clearance: K001899. Product: NX3 Try-In Gel. The product is used as a tooth shade resin material.. Reason: 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..

Recalling firm: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Classification: Class II
Status: Terminated
Initiated: 2013-09-13
Terminated: 2014-02-11
Firm location: Orange, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K001899 — IMPROVED TRY-IN GELSybron Dental Specialties, Inc.·cleared 2000-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.