Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015509619

FEI Number

3015509619

Entity Name

DURR DENTAL SE

City/State/Country

Bietigheim-Bissingen Baden-Wurttemberg, DE

Establishment Address

Hopfigheimer Str. 17, Bietigheim-Bissingen Baden-Wurttemberg 74321, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DURR DENTAL SE (Owner Number: 10047925)

Owner / Operator Contact Address

Hopfigheimer Str. 17, Bietigheim-Bissingen, DE-BW 74321, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213326

PMA Number

N/A

All Registered Proprietary Names

VistaPosition Endo VistaPosition Anterior VistaPosition Bitewing VistaPosition Posterior ProVecta 3D Prime with VisionX 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 ScanX Classic View ScanX Swift View ScanX Intraoral View CamX Triton HD Spectra CamX Spectra VisionX 4 VistaSoft 4 ScanX Swift 2 ScanX Swift View 2 CamX Elara CamX Triton HD Cam Mojave Mobile Mojave Mobile with Amalgam Separator VS 250 S (VacStar Viper) CamX Triton HD Handpiece Universal Cannula Protect, d=16 mm, grey Prophylaxis Cannula, d=16 mm, grey Y-Adapter Set Adapter 16-11 Adapter 11 to 16mm for HVE Air Protect XL, XL Plus Universal Cannula, d=16 mm, grey HVE Air Protect XL, gray HVE Y-Adapter (11 to 16mm for HVE Air Protect XL Plus) HVE Air Protect XL Plus, gray VisionX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2019-05-10
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
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2019-09-17
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-05-10
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2016-02-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-08-29
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-02-24
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2014-11-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2020-06-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-03-22

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
3001052305	Durr Optronik GmbH & Co. KG	Gechingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

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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3011944170	ZAPALIGN INC.	Anyang-si Gyeonggi, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015509619. Last updated year: 2026. Please use registration number 3015509619 when referencing this establishment in official correspondence.