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HP-3

by J.F. Jelenko & Co., Inc. 510(k)

Active United States

510(k) K923718

Overview

The HP-3 is a Gold-Based Noble Metal Alloy device used in dental applications. It is classified as a Class II medical device and is manufactured by J.F. Jelenko & Co., Inc.

The device is supplied as a single-use product and is not MRI compatible. It is stored at room temperature and has received FDA 510(k) clearance with the product code EJT, indicating it is substantially equivalent to predicate devices.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923718 Date5 Mar 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the HP-3 device used for in dental applications?

    The HP-3 is a Gold-Based Noble Metal Alloy device specifically designed for dental applications. It is classified as a Class II medical device and is intended for use in dental procedures where this type of alloy is appropriate.

  • How is the HP-3 device supplied and can it be reused?

    The HP-3 is supplied as a single-use product, meaning it is designed for one-time use only and should not be reused for patient safety and regulatory compliance reasons.

  • What are the storage requirements for the HP-3 dental alloy?

    The HP-3 dental alloy should be stored at room temperature to maintain its integrity and effectiveness until use. Proper storage conditions help ensure the device remains in optimal condition for its intended dental application.

  • Is the HP-3 device MRI compatible?

    No, the HP-3 device is not MRI compatible. This means it should not be used in MRI environments as it may interfere with the imaging process or pose safety risks.