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Sequel (Casting Alloy for Porcelain-Fused-Metal)

by Deringer-Ney, Inc.

510(k) K893800

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 NumberK893800 Date20 Dec 1989ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Sequel casting alloy is a noble‑metal dental alloy intended for the fabrication of cast or porcelain‑fused‑to‑metal crown and bridge restorations. It is composed primarily of gold‑based noble metals and is used by dental laboratories to produce durable, metal‑substructure restorations that receive a porcelain overlay.

The alloy is supplied by Deringer‑Ney, Inc. and is classified as a Class II device (product code EJT) cleared through a traditional FDA 510(k) submission (K893800) with a decision of substantially equivalent. It is regulated under the dental advisory committee and is intended for use in a dental laboratory setting; the device is provided as a casting material and must be stored according to the manufacturer’s instructions.

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