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Excelsior Porcelain System

by Ney Dental, Inc.

510(k) K984427

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 NumberK984427 Date15 Mar 1999ClearedStatusActive

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  • Withdrawn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
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Excelsior Porcelain System is a dental device used in restorative dentistry for the fabrication of porcelain restorations. It is designed to support the creation of dental prostheses such as crowns, bridges, and veneers through a standardized system of materials and components.

The system is supplied as a non-sterile, reusable device intended for use in dental laboratory and clinical settings. It does not require sterilization prior to use as it is not in direct contact with sterile tissue, and there is no indication of MRI safety concerns in the provided data. The device received FDA 510(k) clearance (K984427) on March 15, 1999, and is classified under product code EIH with review by the Dental advisory committee.

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Questions

AI-generated answers, 23 Sep 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 the Excelsior Porcelain System used for?

    The Excelsior Porcelain System is used in restorative dentistry to fabricate porcelain restorations such as crowns, bridges, and veneers. It provides a standardized system of materials and components to support the creation of dental prostheses in both dental laboratory and clinical environments.

  • Is the Excelsior Porcelain System sterile or single-use?

    The Excelsior Porcelain System is supplied as a non-sterile, reusable device. It is not intended for single-use and does not require sterilization prior to use because it does not come into direct contact with sterile tissue during normal operation.

  • What regulatory clearance does the Excelsior Porcelain System have?

    The Excelsior Porcelain System received FDA 510(k) clearance under submission K984427 on March 15, 1999. It was determined to be substantially equivalent to a predicate device and is classified under product code EIH with review by the Dental advisory committee.