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DETAX GmbH & Co. KG

Germany·DE-MF-000005995

Last updated September 17, 2026

What DETAX GmbH & Co. KG makes

DETAX GmbH & Co. KG produces dental materials and devices, including resin-based fabrication materials for dental appliances, silicone impression materials, and custom-made earmoulds. Their portfolio also covers single-use dental impression trays, temporary crown/bridge resins, elastic long-term denture reliners, reusable impression material syringes, and dental composite resins. Specific products include modelling gels, impression materials in bulk and syringe formats, and pre-packaged earmould kits in various sizes and colors.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Unclassified (U), with listings in the EUDAMED registry, FDA’s 510(k) premarket notification database, and FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Germany
Address: 4, Carl-Zeiss-Str. , Ettlingen, Germany
Website: www.detax.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 (0) 7243/510-0
PRRC Contact: Barbara Voigt
EUDAMED SRN: DE-MF-000005995
FDA FEI Number: 1000293792
DUNS Number: —

Catalogue (558)

Page 5 of 12

Device	Model / Reference	Registries	Class	Status
egger LP/W Lack, weich, 100 ml	04480	EUDAMED	Class IIa	Active
Freeprint crown A3, 5 1.000g	04708	EUDAMED	Class IIa	Active
tempofit premium A3 Standardpack.	02209	EUDAMED	Class IIa	Active
tempofit regular A2 Standardpackung	03526	EUDAMED	Class IIa	Active
Medicalprint nobreak purple 1000g	04569	EUDAMED	Class IIa	Active
detax Abdrucklack 1000 ml	02165	EUDAMED	Class IIa	Active
Freeprint tryin A3 385 1.000 g	04428	EUDAMED	Class IIa	Active
tempofit premium BL Standardpack.	04316	EUDAMED	Class IIa	Active
tempofit premium B1	04315	EUDAMEDFDA UDI	Class II	Active
luxaprint 3D shell UV intensive red 500g	03719	FDA UDI	Class I	Unknown
detax softwear 2.0 green 60 shore 2x50ml	04240	FDA UDI	Class I	Active
earflex 25 shore orange 8x50ml	03891	FDA UDI	Class I	Active
medicalprint shell blue opaque 1000g	04164	EUDAMEDFDA UDI	Class I	Active
tempofit premium A1	03248	EUDAMEDFDA UDI	Class II	Active
freeprint mould blue 500 g	03762	FDA UDI	Class I	Unknown
Gingivamoll paint liquid 15 ml	03027	FDA UDI	Class I	Unknown
luxaprint 3D mould UV rose orange 1000 g	03946	FDA UDI	Class I	Active
VITA VIONIC® DENT RESIN B3 1000g	04594	FDA UDI	Class II	Active
freeprint denture pink, 1000 g	02971	FDA UDI	Class II	Active
VITA VIONIC® DENT RESIN D3 500g	04608	EUDAMEDFDA UDI	Class II	Active
easy impression syringe violet	03190	FDA UDI	Class I	Active
earflex white 25 shore 8x50ml	03893	FDA UDI	Class I	Active
Freeprint denture 385 500g	02133	FDA UDI	Class II	Active
OTO Puresil II Muster	03948 / IMPSAMP011	EUDAMED	Class IIa	Active
A-Zoft in bags 2 x 8 g (set of 40)	02822 / 782-50-151-05	EUDAMED	Class IIa	Active
addition spectra Standardpack Auto2	03282	EUDAMED	Class IIa	Active
Detaseal hydroflow lite reg. 4x50 ml	02732	EUDAMED	Class IIa	Active
mollosil Starter-Kit 2 x 30 ml	02274	EUDAMED	Class IIa	Active
pink mix 8 x 50ml	03913	EUDAMED	Class IIa	Active
OTO addition blau Musterpack.	02435	EUDAMED	Class IIa	Active
addition protect 8 x 50 ml	03442	EUDAMED	Class IIa	Active
Akouz heavy rapid 8x50 ml	02962 / 60000662	EUDAMED	Class IIa	Active
OTO Mischkanülen optima 50 St. 6 mm Audio	03187	EUDAMED	Class I	Active
Silaplast FUTUR Standardpack. 900 ml	02001	EUDAMED	Class IIa	Active
Earsil 2 x 660 g grey	02246 / 10950927	EUDAMED	Class IIa	Active
Mischkanülen blau lang 48 St.	02708	EUDAMED	Class I	Active
Detaseal hydroflow xlite fast 2x50 ml	02744	EUDAMED	Class IIa	Active
Proclinic Expert refill tubos	04004	EUDAMED	Class IIa	Active
smartrepair A2	02772	EUDAMED	Class IIa	Active
Anclasil hydroheavy	02859	EUDAMED	Class IIa	Active
Detaseal bite Automix 2 Musterpack.	02211	EUDAMED	Class IIa	Active
Ultraprint-Dental IBT UV 500g	02484	EUDAMED	Class I	Active
luxaprint flex coat 100 ml	04247	EUDAMED	Class IIa	Active
Solflex prov A1 500 g	04146 / REBFP501	EUDAMED	Class IIa	Active
detax flextime Kart.pack. 8x50 ml	02330	EUDAMED	Class IIa	Active
addition protect 50 x 50 ml	03443	EUDAMED	Class IIa	Active
freeprint IBT 385 1000 g	04249	EUDAMEDFDA UDI	Class I	Active
Anclasil hydrofluid regular	02854	EUDAMED	Class IIa	Active
luxaprint shellac Muster 5ml	03596	EUDAMED	Class IIa	Active
luxaprint shellac color braun 50 ml	03995	EUDAMED	Class IIa	Active

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FDA Establishments (1)

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DETAX GmbH US