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Dental Amalgam Alloy

by Dentsply Intl.

510(k) K820389

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820389 Date11 Mar 1982ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1006-2024 FDA Class II initiated 21 Dec 2023

    Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
A Dental Amalgam Alloy (Unnamed
510(k) Number
FDA Product Code
EJJ
Device Class
Class II
Regulation
21 CFR Part 872.3070
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Dental Amalgam Alloy is a dental amalgam alloy. It is classified as an Alloy, Amalgam with product code EJJ.

The device is supplied by Dentsply Intl. and has been cleared by the FDA with a 510K clearance, K820389. It is a Class II device with special controls, and its regulation number is 872.3070. The device was cleared on March 11, 1982.

Other devices from Dentsply Intl.

See all devices from Dentsply Intl. →

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the Dental Amalgam Alloy used for?

    The Dental Amalgam Alloy is used for dental purposes, specifically as a filling material.

  • Is the Dental Amalgam Alloy sterile?

    The device data does not specify the sterility of the Dental Amalgam Alloy, it is recommended to follow proper dental procedures for handling and use.

  • What is the regulatory classification of the Dental Amalgam Alloy?

    The Dental Amalgam Alloy is classified as a Class II device with special controls, and its regulation number is 872.3070.