Nobel Biocare c/o Medicim NV

FDA Device Registration & Listing · Mechelen Antwerpen, BE · Registration 3005739655

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005739655
FEI Number
3005739655
Entity Name
Nobel Biocare c/o Medicim NV
City/State/Country
Mechelen Antwerpen, BE
Establishment Address
Stationsstraat 102, Mechelen Antwerpen B-2800, BE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Nobel Biocare Services AG (Owner Number: 8030879)
Owner / Operator Contact Address
Balz-Zimmermann-Strasse 7, Kloten, CH-ZH 8302, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163122
PMA Number
N/A

All Registered Proprietary Names

DTX Studio Core DTX Studio™ Assist DTX Studio™ AI SDK DTX Studio™ Clinic DTX Studio Clinic DTX Studio™ Clinic IPS CaseDesigner DTX Studio lab DTX Studio design NobelDesign DTX Studio Design DTX Studio Lab DTX Studio diagnose DTX Studio Clinic NobelDesign Software DTX Studio Implant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2019-01-11
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-11-28
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-11-28
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2023-03-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-06-03
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-01-16
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2024-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-12-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-03-11
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2019-03-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-06
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2017-12-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-01-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-06-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-02-16

Official Correspondent

Valeria Barbarito

US Agent Details

John Sharobiem Email: john.sharobiem@envistaco.com Phone: (201) 5297103

Related Public Records

Same Entity

Nobel Biocare Services AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2027971 NOBEL BIOCARE USA, LLC YORBA LINDA, CA, US
3005031178 NOBEL BIOCARE PROCERA, LLC MAHWAH, NJ, US
9611993 NOBEL BIOCARE AB, PRODUKTION KARLSKOGA Orebro, SE
3006540014 NOBEL BIOCARE DISTRIBUTION CENTER BV Venlo Limburg, NL
9611992 NOBEL BIOCARE AB GOTEBORG Vastra Gotaland, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005739655. Last updated year: 2026. Please use registration number 3005739655 when referencing this establishment in official correspondence.
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