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Branemark System Zygomaticus Fixture System

by Nobel Biocare Uas, Inc.

510(k) K970499

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 NumberK970499 Date16 Oct 1997ClearedStatusActive

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
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.

The Brånemark System Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

The device is supplied as part of the Brånemark System Zygoma and is intended for use in dental procedures. It is designed to achieve a passive fit in the final restoration, and it is recommended to use NobelProcera CAD/CAM precision-milled restorations for precision and fit. The device has received FDA 510(k) clearance with the product code DZE and is manufactured by Nobel Biocare Uas, Inc.

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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 the Brånemark System Zygomaticus Fixture System used for?

    The Brånemark System Zygomaticus Fixture System is an endosseous implant made of titanium that is placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth and restore the patient's chewing function.

  • What components are included in the Brånemark System Zygomaticus Fixture System?

    The system includes Fixtures, Drills, Hand Instruments, Cover Screws, and Accessories. It is supplied as part of the Brånemark System Zygoma and is designed to achieve a passive fit in the final restoration.

  • Is the Brånemark System Zygomaticus Fixture System cleared for use in the United States?

    Yes, the device has received FDA 510(k) clearance with the product code DZE and is manufactured by Nobel Biocare Uas, Inc. It was cleared on October 16, 1997.

  • What type of restorations are recommended with this implant system?

    The system is recommended to use NobelProcera CAD/CAM precision-milled restorations for optimal precision and fit in the final restoration, ensuring proper function and aesthetics.