Data / Medical devices / Germany / Dental Direkt GmbH

Dental Direkt GmbH: FDA-registered device maker in Spenge North Rhine-Westphalia, Germany, 11 510(k) clearances

Name: Dental Direkt GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dental Direkt GmbH is registered with the FDA (registration 3008347275) in Spenge North Rhine-Westphalia, Germany. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 6, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008347275
Address: Industriezentrum, Spenge North Rhine-Westphalia, Germany, 32139
Owner or operator: Dental Direkt GmbH (10032224)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: April 1, 2015
Registered through: 2027
Brand names listed: DD Art Elements, DD Basic Shade, DD Bio Splint P HI, DD Bio ZW iso, DD Bio ZX², DD Bio ZX² color, DD Prefab, DD Pro Shade C and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US	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 6, 2024	K241579	DD Hybridlayer (multicolored zirconia)	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
June 23, 2023	K230410	DD medical polymers (PMMA)	EBI	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
April 25, 2023	K230218	DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)	NHA	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
January 11, 2023	K191111	DD Solid Connect® CAD/CAM Abutments	NHA	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
April 16, 2020	K193588	DD Contrast	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
February 14, 2019	K183569	DD cube ONE ML	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
August 1, 2017	K170885	DD cubeX2 HS	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
June 26, 2015	K143071	Nacera Pearl	EIH	Substantially Equivalent	Doceram Medical Ceramics GmbH	accessdata.fda.gov
March 26, 2015	K150196	DD cubeX2	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
February 11, 2015	K142987	DD Bio Z, DD Bio ZX(square), DD BioZX(square) color	EIH	Substantially Equivalent	Dental Direkt of Amerika UG (Haftungsbeschraenkt)	accessdata.fda.gov
August 28, 2012	K112967	PMMA CAD/CAM DISC	EBG	Substantially Equivalent	Polident D.O.O., Dental Products Industry	accessdata.fda.gov

Compare with other makers

Updated September 6, 2024. 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.