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Noris Medical Zygomatic Dental Implant System

by Noris Medical Ltd

510(k) K151909

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 NumberK151909 Date8 Apr 2016ClearedStatusActive

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  • Withdrawn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
FDA applicant
Noris Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Noris Medical Zygomatic Dental Implant System is a bone level implant featuring a 13 mm condensing, variable-threaded, apically tapered design with a long machined-surface neck specifically engineered for placement in the zygomatic region of the atrophic maxilla. It is an internal connection implant with a hexagon shape and internal bevel, designed for tissue level placement with a straight head and tapered body with v-shaped threads.

The system is supplied for use in dental procedures and is intended for graftless treatment, remote anchorage, and full-arch rehabilitation in cases of severe maxillary atrophy. It is manufactured by Noris Medical Ltd and has received FDA 510(k) clearance with the product code DZE. The device is designed to be used in clinical settings by qualified dental professionals.

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Questions

AI-generated answers, 26 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 Noris Medical Zygomatic Dental Implant System used for?

    This system is intended for graftless treatment, remote anchorage, and full-arch rehabilitation in patients with severe maxillary atrophy where traditional implants cannot be placed.

  • How is the implant system supplied?

    The system is supplied for use in dental procedures and is intended for clinical settings by qualified dental professionals.

  • What is the design of the implant?

    It features a 13 mm condensing, variable-threaded, apically tapered design with a long machined-surface neck, internal connection, and hexagon shape.

  • What is the regulatory status of the device?

    The device has received FDA 510(k) clearance with the product code DZE.