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HERACERAM 75

by Jelenko Co.

510(k) K010416

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 NumberK010416 Date8 Mar 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  • Withdrawn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, 1 Oct 2026

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

HERACERAM 75 is a noble metal alloy composed primarily of noble metals such as gold, palladium, platinum, or silver. It is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

The device is supplied by Jelenko Co. and is classified as a Class II medical device with product code EJT. It received FDA 510(k) clearance on March 8, 2001, with the K number K010416, and is regulated under number 872.3060.

Other devices from Jelenko Co.

See all devices from Jelenko Co. →

Questions

AI-generated answers, 1 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 HERACERAM 75 used for?

    HERACERAM 75 is a noble metal alloy intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations in dental applications.

  • How is HERACERAM 75 supplied?

    HERACERAM 75 is supplied by Jelenko Co. as a Class II medical device with product code EJT, designed for dental professionals to create durable dental restorations.

  • What regulatory approvals does HERACERAM 75 have?

    HERACERAM 75 received FDA 510(k) clearance on March 8, 2001, with K number K010416, and is regulated under number 872.3060 as a substantially equivalent device.

  • What metals are included in HERACERAM 75?

    HERACERAM 75 is composed primarily of noble metals such as gold, palladium, platinum, or silver, providing strength and biocompatibility for dental applications.