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Symphony

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

Active United States

510(k) K923714

Overview

The Symphony is a dental device classified as an Alloy, Gold-Based Noble Metal. It is a dental material used for restorative and prosthetic applications in dentistry.

The Symphony is supplied as a Class II medical device with FDA 510(k) clearance (K923714) and is regulated under product code EJT. It is manufactured by J.F. Jelenko & Co., Inc. and is available in various sizes as indicated by the multiple registration numbers provided.

AI-generated from registry data, 24 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 NumberK923714 Date16 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

Other devices from J.F. Jelenko & Co., Inc.

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Questions

  • What is the SYMPHONY dental device used for?

    The SYMPHONY is a dental material classified as a gold-based noble metal alloy, specifically designed for restorative and prosthetic applications in dentistry. It is supplied as a Class II medical device with FDA 510(k) clearance.

  • How is the SYMPHONY dental alloy supplied and what sizes are available?

    The SYMPHONY is supplied as a Class II medical device with FDA 510(k) clearance and is available in various sizes as indicated by the multiple registration numbers provided. The manufacturer is J.F. Jelenko & Co., Inc.

  • What is the regulatory status of the SYMPHONY dental device?

    The SYMPHONY has FDA 510(k) clearance with K number K923714 and is regulated under product code EJT. It was classified as substantially equivalent by the Dental advisory committee in 1993.

  • Is the SYMPHONY dental alloy sterile and can it be reused?

    The device data does not specify sterility status or whether the SYMPHONY is single-use or reusable. For specific handling instructions, users should consult the product documentation provided by the manufacturer.