Durr Optronik GmbH & Co. KG

FDA Device Registration & Listing · Gechingen Baden-Wurttemberg, DE · Registration 3001052305

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
3001052305
FEI Number
3001052305
Entity Name
Durr Optronik GmbH & Co. KG
City/State/Country
Gechingen Baden-Wurttemberg, DE
Establishment Address
Gultlinger Str. 14, Gechingen Baden-Wurttemberg 75391, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DURR DENTAL SE (Owner Number: 10047925)
Owner / Operator Contact Address
Hopfigheimer Str. 17, Bietigheim-Bissingen, DE-BW 74321, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203116
PMA Number
N/A

All Registered Proprietary Names

CamX Elara CamX Triton HD Cam Mojave Mobile Mojave Mobile with Amalgam Separator VS 250 S (VacStar Viper) CamX Triton HD Handpiece ScanX Classic View ScanX Swift View ScanX Intraoral View VistaPosition Endo VistaPosition Anterior VistaPosition Bitewing VistaPosition Posterior CamX Triton HD Camera Sheath ProVecta 3D Prime Ceph ProVecta 3D Prime Phosphor Storage Plate IDX S1 Phosphor Storage Plate IDX S2 Phosphor Storage Plate IDX S0 Phosphor Storage Plate IDX S3 Phosphor Storage Plate IDX S4 CamX Triton HD Spectra CamX Spectra ScanX Swift 2 ScanX Swift View 2 VisionX ProVecta 3D Prime with VisionX ProVecta 3D Prime Ceph ProVecta 3D Prime SensorX Size #1 SensorX Size #2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2014-11-17
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2017-05-10
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2019-05-10
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2019-07-01
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2020-03-06
IWZ Film, Radiographic Radiology Class 1 892.1840 2019-09-17
NBL Laser, Fluorescence Caries Detection Dental Class 2 872.1745 2016-02-08
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2023-02-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-03-22
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2018-08-22
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-08-22
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-01-11
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2024-01-11
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2021-03-24

Official Correspondent

Oliver Lange

US Agent Details

Joseph Latkowski Business: Air Techniques, Inc. Email: Joseph.Latkowski@airtechniques.com Phone: (516) 2145574

Related Public Records

Same Entity

DURR DENTAL SE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015509619 DURR DENTAL SE Bietigheim-Bissingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

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 3001052305. Last updated year: 2026. Please use registration number 3001052305 when referencing this establishment in official correspondence.
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