Alpha-Dent Root Canal Sealer & Filler

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K963922 ↗

FDA Product Code

KIF

Device Class

Class II

Regulation

21 CFR Part 872.3820

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Alpha-Lock or Pro-Lock Fluoride Releasing Glass Ionomer Band Cement

  Class II

  FDA 510(k) K942596 Active Cleared 16 Jun 1994

• Aurofil

  Class II

  FDA 510(k) K781687 Active Cleared 4 Dec 1978

• Alpha-Dent Light Activated Core Buildup Blue Paste

  Class II

  FDA 510(k) K932886 Active Cleared 29 Sep 1993

• Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix Adhesive

  Class II

  FDA 510(k) K942727 Active Cleared 23 Aug 1994

• Alpha-Dent Hema Desentizer(748-000)/With Fluoride(747-000)

  Class II

  FDA 510(k) K960365 Active Cleared 28 Mar 1996

• Hydroxylate Dental Composite Restroative

  Class II

  FDA 510(k) K802535 Active Cleared 18 Dec 1980

See all devices from Wallace A. Erickson & Co. →