Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004982293

FEI Number

3004982293

Entity Name

ZEBRIS MEDICAL GMBH

City/State/Country

Isny Baden-Wurttemberg, DE

Establishment Address

Am Galgenbuehl 14, Isny Baden-Wurttemberg 88316, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

zebris Medical GmbH (Owner Number: 9069902)

Owner / Operator Contact Address

Am Galgenbuehl 14, --, Isny, DE-BW 88316, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FDM-S FDM-1.5 FDM-3 FDM-2 FDM-SX JMT+, JMAnalyser+ JMA-Optic JMA-Optic AG "zebris for ceramill" PlaneAnalyser II Accessories: Alignment Spoon; Paraocclusal Attachment; Paraocclusal Attachment with Lip Arch; Accessories: Occlusal Attachment UN; Bite Fork UN; Bite Fork Adapter UN; Bite Fork PS1; Fusion Bite; Fusion Bite Adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2013-11-04
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	Class 1	872.2060	2005-01-27

Official Correspondent

Matthias Hagmann

US Agent Details

Alison Fahy Business: Noraxon USA, Inc. Email: alison.fahy@noraxon.com Phone: (480) 4433413

Related Public Records

Same Entity

zebris Medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004982293. Last updated year: 2026. Please use registration number 3004982293 when referencing this establishment in official correspondence.