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Blengold Special

by Heraeus Dental Gold Corp.

510(k) K851872

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK851872 Date2 Jul 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
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.

Blengold Special is a gold-based noble metal alloy intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. It is a Class II device with special controls.

The device is supplied by Heraeus Dental Gold Corp. and has FDA 510(k) clearance with product code EJT under regulation number 872.3060. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Other devices from Heraeus Dental Gold Corp.

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 Blengold Special used for in dental applications?

    Blengold Special is a gold-based noble metal alloy intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. It is designed to provide durability and biocompatibility for dental prosthetics.

  • How is Blengold Special supplied and what is its regulatory status?

    Blengold Special is supplied by Heraeus Dental Gold Corp. It has FDA 510(k) clearance with product code EJT under regulation number 872.3060. It is classified as a Class II device with special controls.

  • Is Blengold Special single-use or reusable, and what information is available about sterility?

    The device is not specified as single-use or reusable in the provided information. No details regarding sterility, MRI safety, or storage conditions are available in the device data.

  • What distinguishes Blengold Special from other dental alloys?

    Blengold Special is distinguished as a gold-based noble metal alloy specifically designed for crown and bridge restorations. Its unique composition and FDA clearance with product code EJT differentiate it from other dental materials available in the market.