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Alpha-Dent Zinc Oxide Eugenol Temporary Cement

by Wallace A. Erickson & Co. 510(k)

Active United States

510(k) K955089

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955089 Date13 Dec 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Zinc Oxide Eugenol Temporary Cement, classified as a dental cement under FDA category EMA. It is designed to serve as a temporary dental filling, a base cement for affixing temporary restorations, or a protective layer for dental pulp. The material is composed of zinc oxide and eugenol, providing temporary mechanical support and pulp protection in restorative dentistry.

The cement is supplied as a single-use dental material, intended for use in clinical settings by dental professionals. It is not sterile at the point of sale but is typically sterilized or prepared under aseptic conditions prior to application. No MRI safety information is specified, and the device is classified as Class II under FDA regulations (21 CFR 872.3275). The product holds an FDA 510(k) clearance (K955089) with a decision date of December 13, 1995, and is regulated as a dental cement under the Dental advisory committee.

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