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XeraFit

by Metalor Technologies USA

510(k) K020062

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 NumberK020062 Date14 Feb 2002ClearedStatusActive

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  • Withdrawn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
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 XeraFit is a Base Metal Alloy designed for dental applications, specifically for porcelain-to-metal restorations. It is a metallic material engineered to bond with porcelain in dental prosthetics, ensuring durability and compatibility with dental ceramics.

This alloy is supplied as a reusable dental material, intended for use in clinical settings by dental professionals. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K020062) for dental use. The product adheres to regulatory standards for base metal alloys in restorative dentistry, with no specific sterility or single-use designation noted in the data.

Other devices from Metalor Technologies USA

Questions

AI-generated answers, 19 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 XeraFit alloy primarily used for in dental applications?

    The XeraFit is specifically designed for porcelain-to-metal restorations in dentistry. It serves as a base metal alloy that bonds with porcelain in dental prosthetics, ensuring durability and compatibility with dental ceramics for crowns, bridges, or other fixed restorations.

  • Is the XeraFit intended for single-use or reusable applications in a clinical setting?

    The XeraFit is supplied as a reusable dental material, intended for use by dental professionals in clinical settings. It is not designated as single-use, meaning it can be processed and reused multiple times under proper conditions.

  • How was the regulatory pathway for the XeraFit determined, and what does this mean for its use?

    The XeraFit received FDA 510(k) clearance (K020062) through a traditional review process, classified as a Class II device. This means it was determined to be substantially equivalent to a legally marketed predicate device, confirming its safety and effectiveness for its intended dental use in porcelain-to-metal restorations.

  • Are there any specific storage requirements or considerations for the XeraFit alloy?

    The provided data does not specify storage requirements for the XeraFit alloy. However, as a reusable dental material, it should be stored in a clean, dry environment to prevent contamination and maintain its integrity for repeated use in clinical settings.

  • What does the product code (EJH) and advisory committee (DE) designation indicate about the XeraFit?

    The product code EJH categorizes the XeraFit under dental alloys, specifically for use in restorative dentistry. The Dental Expert Panel (DE) advisory committee designation indicates that the device was reviewed by dental specialists during the FDA 510(k) submission process, ensuring its technical and clinical suitability for porcelain-to-metal applications.