Improved Try-in Gel

• • Terminated Z-1824-2020 FDA Class II ·initiated 25 Feb 2020 ·on shared 510(k) K001899

  An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.

• • Terminated Z-2259-2013 FDA Class II ·initiated 13 Sep 2013

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001899 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Sealapex 4

  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →