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KDF Zirconia Disc

by Denken-Highdental Co., Ltd. 510(k)

Active United States

510(k) K221429

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221429 Date14 Jul 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The KDF Zirconia Disc is a dental appliance fabrication material composed of ceramic. It is designed to be used in the creation of dental restorations.

This device is available in 18 different shades and is organized into three distinct series. It has received FDA 510(k) clearance under the traditional pathway, identified by K221429.

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Questions

AI-generated answers, 6 Oct 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 KDF Zirconia Disc used for?

    The KDF Zirconia Disc is a ceramic material specifically engineered for the fabrication of dental restorations. It serves as the base material for dental appliances produced in a laboratory setting.

  • What shade options are available for this zirconia disc?

    The device is available in 18 different shades to accommodate various clinical requirements and is organized into three distinct series to assist with material selection.

  • What is the regulatory status of the KDF Zirconia Disc?

    The KDF Zirconia Disc has received FDA 510(k) clearance under the traditional pathway, identified by the K-number K221429, confirming it has been found substantially equivalent to predicate devices.