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IMZ - Dental Implant Surgical Tray

by Imz, GmbH

510(k) K951609

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 NumberK951609 Date1 Aug 1995ClearedStatusActive

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  • Withdrawn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, 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 IMZ - Dental Implant Surgical Tray is a device designed for dental implant procedures. It is part of the IMZ dental implant system and is intended to assist in the surgical placement of dental implants.

The tray is supplied as a single-use device and is not reusable. It is not specified whether the tray is sterile or non-sterile. The device is not MRI safe. The tray is available in unspecified sizes. The device has received FDA 510(k) clearance (K951609) and is classified under product code DZE.

Other devices from Imz, GmbH

See all devices from Imz, GmbH →

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 IMZ Dental Implant Surgical Tray used for?

    The IMZ Dental Implant Surgical Tray is designed to assist in the surgical placement of dental implants as part of the IMZ dental implant system.

  • Is the IMZ Dental Implant Surgical Tray reusable?

    No, the IMZ Dental Implant Surgical Tray is supplied as a single-use device and is not reusable.

  • Is the IMZ Dental Implant Surgical Tray sterile?

    The device data does not specify whether the tray is sterile or non-sterile.

  • Is the IMZ Dental Implant Surgical Tray MRI safe?

    No, the IMZ Dental Implant Surgical Tray is not MRI safe.

  • What is the regulatory status of the IMZ Dental Implant Surgical Tray?

    The IMZ Dental Implant Surgical Tray has received FDA 510(k) clearance (K951609) and is classified under product code DZE.