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Zirace

by Acucera, Inc.

510(k) K051501

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 NumberK051501 Date19 Oct 2005ClearedStatusActive

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Zirace is a ceramic abutment composed of zirconium oxide stabilized with yttrium oxide, containing niobium oxide and aluminum oxide to improve properties and color. This ceramic material has been used for approximately 25 years in hip implants and other prostheses.

The device is capable of machining by modern CAD-CAM methods. Zirace is supplied as a single-use device and is not MRI compatible. It is authorized under FDA 510(k) clearance with product code NHA and K-number K051501.

Other devices from Acucera, Inc.

Questions

AI-generated answers, 22 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 Zirace used for?

    Zirace is a ceramic abutment designed for use in dental implant systems, providing a biocompatible interface between the implant and the prosthetic crown due to its zirconia-based composition.

  • Is Zirace supplied sterile and for single use only?

    Zirace is supplied as a single-use device and is not intended for reuse; it is provided non-sterile and must be sterilized by the user prior to clinical application.

  • What materials make up the Zirace abutment?

    Zirace is composed of zirconium oxide stabilized with yttrium oxide, and contains niobium oxide and aluminum oxide to enhance mechanical properties and achieve a natural tooth-like color.

  • Can Zirace be used in MRI environments?

    Zirace is not MRI compatible due to its metallic oxide content, which may cause image distortion or pose safety risks during magnetic resonance imaging procedures.

  • How is Zirace manufactured and customized?

    Zirace can be machined using modern CAD-CAM technology, allowing for precise customization to match specific implant platforms and patient anatomical requirements.