Tytin R

• • Terminated Z-1788-2014 FDA Class II ·initiated 29 May 2014

  Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.

510(k) Number

K951663 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Handpiece, Lift, Endo

  Class I

  FDA 510(k) K780213 Active Cleared 17 Feb 1978

• Kerr Gelled Phosphoric Acid Etchant

  Class II

  FDA 510(k) K843026 Active Cleared 27 Sep 1984

• Kerr Cavalite

  Class II

  FDA 510(k) K872147 Active Cleared 26 Aug 1987

• Kerr Xr Bond

  Class II

  FDA 510(k) K880250 Active Cleared 1 Jun 1988

• Ever-Bond V Glass Lonomer Restorative

  Class II

  FDA 510(k) K843072 Active Cleared 7 Sep 1984

• Kerr Discovery Disposable Fluoride Tray

  Class I

  FDA 510(k) K780712 Active Cleared 17 May 1978

See all devices from Kerr Corporation (Danbury) →