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ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

by Zirkonzahn SRL

510(k) K203765

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203765↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK203765 Date20 Jul 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Zirkonzahn Implant-Planner and related software tools are digital planning and conversion systems for dental implantology. These devices assist clinicians in designing implant placements, generating STL files for CAD/CAM workflows, and creating custom surgical guides (Z-Trays) to enhance precision in implant surgery.

Supplied as software applications, these tools are intended for use in dental practices and laboratories. They require a compatible computer system and may be used in conjunction with intraoral scanners or other imaging modalities. The devices are classified under the product code LLZ and have received FDA 510(k) clearance and MDR authorization. No sterility or single-use requirements are specified, as these are software-based solutions.

Other devices from Zirkonzahn GmbH

See all devices from Zirkonzahn GmbH →

Questions

AI-generated answers, 18 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 types of dental procedures can the Zirkonzahn Implant-Planner software assist with, and how does it integrate with existing workflows?

    The Zirkonzahn Implant-Planner software is designed to assist with dental implant planning, including the precise design of implant placements and the creation of STL files for CAD/CAM workflows. It integrates with intraoral scanners or other imaging tools to generate custom surgical guides (Z-Trays), improving accuracy in implant surgery. Since it is software-based, it requires a compatible computer system and can be used alongside existing digital imaging and scanning equipment in dental practices or labs.

  • Are there different versions of the Zirkonzahn software, and how do they differ in terms of intended use?

    Yes, there are multiple software tools under the Zirkonzahn brand: the Implant-Planner and Implant-Planner Practice (likely tailored for individual clinicians and larger practices, respectively), as well as the CAD/CAM STL Converter and CAD/CAM Z-Tray modules. While all assist in digital implant planning and workflow optimization, the Practice version may offer additional features or scalability for multi-user environments. The Z-Tray specifically focuses on generating custom surgical guides, while the STL Converter facilitates file compatibility for CAD/CAM fabrication.

  • How is the Zirkonzahn software regulated, and what does that mean for my practice’s compliance?

    The Zirkonzahn software tools have received FDA 510(k) clearance and MDR authorization, confirming they meet regulatory standards for digital planning and conversion systems in dental implantology. Since these are software-based solutions, they are classified under product code LLZ (Radiology) and do not require sterility or single-use considerations. Your practice must ensure your computer systems meet the manufacturer’s compatibility requirements, but no additional regulatory steps are needed beyond standard software installation and maintenance.

  • Is the Zirkonzahn software compatible with any specific hardware or imaging systems, and what are the system requirements?

    The software is designed to work with compatible computer systems and can integrate with intraoral scanners or other imaging modalities commonly used in dental practices. While the exact hardware specifications (e.g., operating system, RAM, or processor requirements) are not detailed in the data, the manufacturer likely provides these in their documentation. Since it’s a digital tool, compatibility depends on meeting the system prerequisites outlined by Zirkonzahn SRL for optimal performance.

  • Can the Zirkonzahn software be used for both planning and fabricating surgical guides, or are those separate functions?

    The software serves both planning and guide-fabrication functions. The Implant-Planner tools assist in designing implant placements and generating STL files for CAD/CAM workflows, while the CAD/CAM Z-Tray module specifically creates custom surgical guides (Z-Trays) based on those digital designs. This streamlines the process from planning to fabrication, reducing manual steps and improving precision in implant surgery.