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Dental Porcelain-Various

by Excelco Intl., Inc. 510(k)

Active United States

510(k) K851733

Overview

Dental Porcelain-Various is a dental device used for various dental applications. It is a porcelain material designed for use in dental procedures and laboratory work.

The device is supplied as a powdered porcelain material and is used in dental laboratories. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is authorized under FDA 510K clearance with product code ELL.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851733 Date16 Oct 1985ClearedStatusActive

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
ELL
Device Class
Class II
Regulation
21 CFR Part 872.3920
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Questions

  • What is Dental Porcelain-Various used for?

    Dental Porcelain-Various is a dental device used for various dental applications and laboratory work. It is a porcelain material designed specifically for use in dental procedures.

  • How is Dental Porcelain-Various supplied?

    The device is supplied as a powdered porcelain material intended for use in dental laboratories. No information is provided regarding single-use or reuse status.

  • What is the regulatory status of Dental Porcelain-Various?

    Dental Porcelain-Various is authorized under FDA 510K clearance with product code ELL. It has been determined to be substantially equivalent to other devices in this category.

  • Is MRI safety information available for Dental Porcelain-Various?

    No MRI safety information is provided for Dental Porcelain-Various. The device description does not include any details regarding its safety in MRI environments.