Data / Medical devices / Belgium / Nobel Biocare c/o Medicim NV

Nobel Biocare c/o Medicim NV: FDA-registered device maker in Mechelen Antwerpen, Belgium, 12 510(k) clearances

Name: Nobel Biocare c/o Medicim NV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nobel Biocare c/o Medicim NV is registered with the FDA (registration 3005739655) in Mechelen Antwerpen, Belgium. It lists 7 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 17, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005739655
Address: Stationsstraat 102, Mechelen Antwerpen, Belgium, B-2800
Owner or operator: Nobel Biocare Services AG (8030879)
Roles: Complaint file establishment, Manufacturer
First device listed: June 6, 2016
Registered through: 2027
Brand names listed: DTX Studio Clinic, DTX Studio Core, DTX Studio Design, DTX Studio Implant, DTX Studio Lab, DTX Studio design, DTX Studio diagnose, DTX Studio lab and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Analyzer, Medical Image	MYN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment, 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
November 17, 2025	K252086	DTX Studio Assist	MYN	Substantially Equivalent	Nobel Biocare C/O Medicim NV	accessdata.fda.gov
December 8, 2023	K231898	DTX Studio Clinic (4.0)	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
March 28, 2023	K221921	DTX Studio Clinic 3.0	MYN	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
March 25, 2022	K213562	DTX Studio Clinic 3.0	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
November 20, 2020	K203156	DTX Studio Clinic	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
October 8, 2020	K200810	IPS CaseDesigner	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
March 1, 2019	K181932	DTX Studio design	PNP	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
January 11, 2018	K172224	DTX Studio diagnose	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
November 29, 2017	K171466	NobelDesign, DTX Studio Design	NHA	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
January 31, 2017	K163122	NobelClinician, DTX Studio implant	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
November 10, 2016	K161634	IPS CaseDesigner	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
June 2, 2016	K153036	NobelDesign Software	NHA	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov

Compare with other makers

Updated November 17, 2025. 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.