Kerr Porcelite

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K860346 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

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) →

• What is the primary use of Kerr Porcelite?

  Kerr Porcelite is a dental resin bonding agent used to facilitate the attachment of restorative components to the natural tooth structure.

• How is this device regulated?

  Kerr Porcelite is classified as a Class II dental device under regulation number 872.3200 and has received FDA 510(k) clearance under reference number K860346.

• Who is the manufacturer of this bonding agent?

  This device is manufactured by the Kerr Corporation, based in Danbury.