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Gold Core 73 LS

by Jeneric/Pentron, Inc.

510(k) K011362

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 NumberK011362 Date29 May 2001ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The device is an alloy, gold-based noble metal, as defined in the FDA 510(k) clearance K011362. It is classified as a dental device under product code EJT and regulation number 872.3060.

It was cleared via the traditional 510(k) pathway on May 29, 2001, by Jeneric/Pentron, Inc. The device is supplied as a material for dental restorations and is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Other devices from Jeneric/Pentron, Inc.

See all devices from Jeneric/Pentron, Inc. →

Questions

AI-generated answers, 6 Oct 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 GOLD CORE 73 LS used for?

    GOLD CORE 73 LS is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations, as specified in its FDA 510(k) clearance K011362 under product code EJT and regulation 872.3060.

  • How is GOLD CORE 73 LS supplied?

    The device is supplied as a material for dental restorations, specifically as an alloy, gold-based noble metal, for use in dental laboratory fabrication processes.

  • Is GOLD CORE 73 LS a single-use or reusable device?

    GOLD CORE 73 LS is a dental alloy material intended for use in the fabrication of restorations; it is not a finished device that is reused, but rather a raw material consumed during the casting or porcelain-fusing process to create a final restoration.

  • What regulatory pathway was used for GOLD CORE 73 LS?

    GOLD CORE 73 LS was cleared via the traditional 510(k) pathway on May 29, 2001, under submission K011362 by Jeneric/Pentron, Inc., demonstrating substantial equivalence to a predicate device.

  • Who manufactures GOLD CORE 73 LS?

    GOLD CORE 73 LS is manufactured by Jeneric/Pentron, Inc., located at 53 N. Plains Industrial Rd., P.O. Box 724, Wallingford, CT 06492, United States.