Data / Medical devices / Germany / Detax GMBH

Detax GMBH: FDA-registered device maker in ETTLINGEN Baden-Wurttemberg, Germany, 8 510(k) clearances

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

Detax GMBH is registered with the FDA (registration 9680954) in ETTLINGEN Baden-Wurttemberg, Germany. It lists 16 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 30, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9680954
FEI number: 1000293792
Address: Carl-Zeiss-Str. 4, ETTLINGEN Baden-Wurttemberg, Germany, D-76275
Owner or operator: DETAX GMBH (9012556)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 6, 1995
Registered through: 2026
Brand names listed: FREEPRINT crown A3,5 1000g, FREEPRINT crown A3,5 500g, FREEPRINT splintmaster flex 1000g, FREEPRINT splintmaster taff 1000g, FREEPRINT® crown A3,5 1000g, FREEPRINT® crown A3,5 500g, FREEPRINT® denture impact pink 1000 g, FREEPRINT® denture impact pink-transparent 1000 g and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Contract manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Protector, Hearing (Insert)	EWD	U	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Syringe, Ent	KCP	1	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer, Repackager or relabeler	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
October 30, 2025	K252430	Freeprint® denture flex	EBI	Substantially Equivalent	Detax GmbH	accessdata.fda.gov
October 12, 2023	K232448	FREEPRINT® splintmaster	MQC	Substantially Equivalent	Detax GmbH	accessdata.fda.gov
September 23, 2022	K222877	FREEPRINT crown	EBF	Substantially Equivalent	Detax GmbH	accessdata.fda.gov
November 16, 2020	K200461	Freeprint denture	EBI	Substantially Equivalent	Detax GmbH & Co. KG	accessdata.fda.gov
October 27, 2020	K200273	FREEPRINT temp	EBG	Substantially Equivalent	Detax GmbH & Co. KG	accessdata.fda.gov
March 13, 2017	K162654	mollosil plus	EBI	Substantially Equivalent	Detax GmbH & Co. KG	accessdata.fda.gov
July 23, 2010	K100247	DETAX IMPLANTLINK SEMI	EMA	Substantially Equivalent	Detax GmbH & Co. KG	accessdata.fda.gov
February 16, 2000	K994012	TEMPOFIT, MODEL 02693	EBG	Substantially Equivalent	Detax GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated October 30, 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.