Data / Medical devices / Germany / Durr Optronik GmbH & Co. KG

Durr Optronik GmbH & Co. KG: FDA-registered device maker in Gechingen Baden-Wurttemberg, Germany, 12 510(k) clearances

Name: Durr Optronik GmbH & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Durr Optronik GmbH & Co. KG is registered with the FDA (registration 3001052305) in Gechingen Baden-Wurttemberg, Germany. It lists 9 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3001052305
Address: Gultlinger Str. 14, Gechingen Baden-Wurttemberg, Germany, 75391
Owner or operator: DURR DENTAL SE (10047925)
Roles: Manufacturer, Repackager or relabeler
First device listed: November 17, 2014
Registered through: 2027
Brand names listed: CamX Elara, CamX Spectra, CamX Triton HD Cam, CamX Triton HD Camera Sheath, CamX Triton HD Handpiece, CamX Triton HD Proxi, CamX Triton HD Spectra, Mojave Mobile and more

Devices it lists

Device	Product code	Class	Role	Source
Dental Barriers And Sleeves	PEM	2	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Light Transmission Caries Detector	NTK	2	Manufacturer	accessdata.fda.gov
Light-Induced Fluorescence Caries Detector	NBL	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2023	K232487	Provecta 3D Prime and Provecta 3D Prime Ceph	OAS	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
February 6, 2023	K230095	ScanX Swift 2.0, ScanX Swift View 2.0	MUH	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
November 2, 2021	K213326	VisionX 3.0	LLZ	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
March 19, 2021	K203116	SensorX	MUH	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
October 7, 2020	K202633	ScanX Edge	MUH	Substantially Equivalent	Dürr Dental SE	accessdata.fda.gov
March 5, 2020	K193139	ProVecta 3D Prime Ceph	OAS	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
July 26, 2019	K190949	ScanX Barrier Envelopes	PEM	Substantially Equivalent	Air Techniques, Inc.	accessdata.fda.gov
August 2, 2018	K181432	ProVectra 3D Prime with VistaSoft	OAS	Substantially Equivalent	Durr Dental SE	accessdata.fda.gov
November 22, 2017	K172007	CamX Triton HD Proxi Head	NTK	Substantially Equivalent	Duerr Dental AG	accessdata.fda.gov
May 1, 2017	K170733	ScanX Intraoral View	MUH	Substantially Equivalent	Duerr Dental AG	accessdata.fda.gov
January 27, 2016	K150672	VistaCam iX Proof	NBL	Substantially Equivalent	Durr Dental AG	accessdata.fda.gov
February 18, 2014	K132953	TIDISHEILD	PEM	Substantially Equivalent	Tidi Products,Llc	accessdata.fda.gov

Compare with other makers

Updated September 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.