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Coltène/Whaledent GmbH + Co. KG

Germany·DE-MF-000005717

Last updated May 24, 2026

What Coltène/Whaledent GmbH + Co. KG makes

Coltène/Whaledent GmbH + Co. KG manufactures dental materials for gingival retraction, occlusion assessment, and articulation testing. Their portfolio includes non-medicated gingival retraction cords (e.g., twisted and non-impregnated variants), occlusion foils, articulating papers, and dental rolls for bite registration. Additional items include sterile sleeves for dental instruments and cotton pellets for moisture control.

The company’s products are classified under EU Medical Device Regulations as Class I or Class IIa, with all relevant devices registered in the EU’s eudamed database. 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: 30, Raiffeisenstraße, Langenau, Germany
Website: www.coltene.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 7345 805 0
PRRC Contact: Dimitrij Zeiger
EUDAMED SRN: DE-MF-000005717
FDA FEI Number: —
DUNS Number: 315494443

Catalogue (124)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
roeko GuttaFlow bioseal Standard Set	60019560	EUDAMED	Class IIa	Active
roeko Solomat-Click Refill # 000, 3pcs	214000	EUDAMED	Class I	Active
Dental rolls ROEKO Parotisroll # 5/100pcs	160005	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #3 300g	100003	EUDAMED	Class I	Active
HANEL Articulating paper 40µ U-shaped blue	480337	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #2 1000pcs	104002	EUDAMED	Class I	Active
roeko Comprecap #1, 120 pcs	530008	EUDAMED	Class I	Active
roeko Solomat-Click Refill # 1, 3 psc	214111	EUDAMED	Class I	Active
roeko-Swab/walnut, 1000 pcs.	253003	EUDAMED	Class I	Active
Dental rolls ROEKO Cotton-roll #3 1000pcs	104013	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold Sample, #2/ 40pcs	60022217	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 2sided red	480042	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm red-black	480165	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 80mm 2sided green	480053	EUDAMED	Class I	Active
HANEL Articulating paper 40µ on roll 22mm 2sided red	480322	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 1sided red	480022	EUDAMED	Class I	Active
roeko GuttaFlow2 Standard Set	60026870	EUDAMED	Class IIa	Active
roeko-Swab/plum, 500 pcs.	252004	EUDAMED	Class I	Active
Dental rolls ROEKO Sample Parotisroll #1, 2, 3 / 6pcs	5457	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 1/300 g	109121	EUDAMED	Class I	Active
roeko Cotton pellets # 000, 1.5g	210000	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm 1sided green PET	60022260	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm 1sided red PET	60022259	EUDAMED	Class I	Active
roeko Cotton pellets # 2, 10g	210112	EUDAMED	Class I	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Coltène/Whaledent AG US