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Dental Zirconia Blocks

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192262

by De Corematrix Co., Ltd.

Identifiers

510(k) Number
K192262 FDA 510(k)
FDA Product Code
EIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6660 FDA 510(k)
Regulation Number
872.6660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Dental Zirconia Blocks are ceramic materials used for the fabrication of dental prosthetics. These blocks are designed to provide mechanical properties suitable for the creation of dental restorations.

This device is manufactured by De Corematrix Co., Ltd. and has received FDA 510K clearance. It is categorized under the dental advisory committee and is identified by product code EIH.

Frequently asked questions

What are Dental Zirconia Blocks used for?

These blocks are ceramic materials specifically designed for the fabrication of dental prosthetics. They provide the necessary mechanical properties required to create durable dental restorations.

What is the regulatory status of these zirconia blocks?

The Dental Zirconia Blocks manufactured by De Corematrix Co., Ltd. have received FDA 510K clearance under K-number K192262. This indicates the device has been found substantially equivalent to legally marketed predicate devices.

How are these blocks categorized for regulatory purposes?

The device is categorized under the dental advisory committee and is identified by the product code EIH. This classification helps define the regulatory pathway and standards applicable to the material's use in dental applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Reliable Dental Zirconia Block Manufacturer - De Corematrix, Understanding De Corematrix's Dental Zirconia Block, Zirconium Block Expert In Dental Ceramics Area - De Corematrix

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
De Corematrix Co., Ltd.

Sources (1)

  • FDA 510(k) K192262 24 fields · synced Sep 23, 2026