Dental Cement, Zinc Phosphate

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

510(k) Number

K790593 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

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 Root Canal Sealer & Filler

  Class II

  FDA 510(k) K963922 Active Cleared 6 Dec 1996

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

  Class II

  FDA 510(k) K960365 Active Cleared 28 Mar 1996

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

• What is the primary use of this zinc phosphate dental cement in clinical practice?

  This zinc phosphate dental cement is primarily used as a temporary tooth filling or as a base to secure restorative materials during dental restorations. It is designed to provide temporary support and stability in procedures where permanent materials are not yet placed.

• How is this dental cement supplied, and is it intended for single-use or reuse?

  The cement is supplied as a two-part system, meaning it comes as separate powder and liquid components that must be mixed together before use. It is explicitly intended for single-use applications in dental settings, so each package should only be used once.

• Are there any specific storage requirements mentioned for this product?

  The provided data does not specify detailed storage instructions such as temperature or humidity conditions. However, since it is a dental cement intended for clinical use, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to maintain its efficacy.

• What regulatory pathway was followed for this device’s FDA clearance, and when was it authorized?

  This zinc phosphate dental cement received FDA 510(k) clearance under the traditional review pathway, classified as a Class II medical device. The clearance was granted on June 15, 1979, with the submission originally received on March 26, 1979, and was determined to be *substantially equivalent* to a predicate device.