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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 2 of 3

Device	Model / Reference	Registries	Class	Status
HANEL Articulating paper 40µ strips 22x110 mm blue-red	480354	EUDAMED	Class I	Active
roeko Solomat-N # 0	223110	EUDAMED	Class I	Active
roeko Comprecap anatomic Set, 120 pcs	531299	EUDAMED	Class I	Active
roeko Cotton pellets # 00, 4g	210100	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #3 500pcs	105003	EUDAMED	Class I	Active
roeko Solomat-N # 000	223000	EUDAMED	Class I	Active
roeko GuttaFlow bioseal Mixing Tips, 24 pcs.	60019562	EUDAMED	Class I	Active
Dental rolls ROEKO Cotton-roll #1 1000pcs	104011	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #3 1000pcs	104003	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #1 300g	100001	EUDAMED	Class I	Active
roeko Solomat-N # 2	223112	EUDAMED	Class I	Active
roeko Retracto / braided / non-impregnated, fine (1), 225 cm	511001	EUDAMEDFDA UDI	Class I	Active
Dental rolls ROEKO Luna #4 300g	100004	EUDAMED	Class I	Active
Dental rolls ROEKO Cotton-roll #2 1000pcs	104012	EUDAMED	Class I	Active
roeko Solomat-N # 00	223100	EUDAMED	Class I	Active
Dental rolls ROEKO Parotisroll # 3/100pcs	160003	EUDAMED	Class I	Active
HANEL Articulating paper 200µ strips 18x50 mm red	480392	EUDAMED	Class I	Active
roeko Solomat-N # 1	223111	EUDAMED	Class I	Active
roeko Solomat-Click # 0	224110	EUDAMED	Class I	Active
roeko Solomat-N Refill # 00, 6pcs	213100	EUDAMED	Class I	Active
roeko Solomat-N Refill # 0, 6pcs	213110	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm red-black PET	60022266	EUDAMED	Class I	Active
roeko Comprecap #5, 60 pcs	530014	EUDAMED	Class I	Active
roeko Comprecap anatomic #3, 120 pcs	531203	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #2 300g	100002	EUDAMED	Class I	Active
Dental rolls ROEKO Parotisroll # 2/100pcs	160002	EUDAMED	Class I	Active
Dental rolls ROEKO Parotisroll # 1/100pcs	160001	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold Sample, #2/ 5 pcs	60011784	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 2sided green	480043	EUDAMED	Class I	Active
HANEL Articulating paper 40µ on roll 22mm 2sided blue	480327	EUDAMED	Class I	Active
roeko Comprecap #1, 600 pcs	531008	EUDAMED	Class I	Active
HANEL Articulating paper 40µ strips 22x110 mm red	480352	EUDAMED	Class I	Active
roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm	511000	EUDAMEDFDA UDI	Class I	Active
roeko Retracto / braided / non-impregnated, medium (2), 225 cm	511002	EUDAMEDFDA UDI	Class I	Active
roeko Comprecap Set, 150 pcs	530000	EUDAMED	Class I	Active
roeko Retracto / braided / non-impregnated, thick (3), 225 cm	511003	EUDAMEDFDA UDI	Class I	Active
roeko Cotton pellets # 1, 10g	210111	EUDAMED	Class I	Active
roeko-Swab/pea, 1000 pcs.	253001	EUDAMED	Class I	Active
roeko Comprecap #3, 600 pcs	531010	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm 1sided black PET	60022258	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm 2sided red PET	60022263	EUDAMED	Class I	Active
roeko Retracto / twisted / non-impregnated, x-fine (0), 225 cm	523000	EUDAMEDFDA UDI	Class I	Active
Dental rolls ROEKO Luna #1 1000pcs	104001	EUDAMED	Class I	Active
roeko Stay-put / non-impregnated, fine (1), 183 cm	521001	EUDAMEDFDA UDI	Class I	Active
roeko-Swab/hazelnut, 1000 pcs.	253002	EUDAMED	Class I	Active
roeko-Swab/walnut, 500 pcs.	252003	EUDAMED	Class I	Active
HANEL Articulating paper 80µ U-shaped blue-red	480364	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 2/300 g	109122	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 1/1000pcs	109101	EUDAMED	Class I	Active
HANEL Articulating paper 80µ U-shaped blue	480367	EUDAMED	Class I	Active

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FDA Establishments (1)

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Coltène/Whaledent AG US