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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 (125)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
roeko Retracto / twisted / non-impregnated, fine (1), 225 cm	523001	EUDAMEDFDA UDI	Class I	Active
HANEL Occlusion foil 12µ 80mm 2sided black	480051	EUDAMED	Class I	Active
roeko Steri-sleeve	670101	EUDAMED	Class I	Active
roeko Stay-put / non-impregnated, medium (2), 183 cm	521002	EUDAMEDFDA UDI	Class I	Active
Omnident Wattekügelchen, Größe 00, 4 g	55482	EUDAMED	Class I	Active
HANEL Articulating paper 80µ I-shaped blue	480387	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Sample #2, 5pcs	60013407	EUDAMED	Class I	Active
HANEL Articulating paper 40µ U-shaped red	480332	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #2 500pcs	105002	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 1sided black	480021	EUDAMED	Class I	Active
roeko Solomat-N Refill # 2, 6pcs	213112	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 2/1000pcs	109102	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 3/1000pcs	109103	EUDAMED	Class I	Active
roeko Stay-put / non-impregnated, thick (3), 183 cm	521003	EUDAMEDFDA UDI	Class I	Active
roeko Solomat-N Refill # 1, 6pcs	213111	EUDAMED	Class I	Active
roeko Comprecap anatomic #1, 120 pcs	531201	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 80mm 1sided red	480032	EUDAMED	Class I	Active
roeko-Swab/egg, 500 pcs.	252005	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 1sided green	480023	EUDAMED	Class I	Active
roeko Cotton pellets # 0, 4g	210110	EUDAMED	Class I	Active
roeko Solomat-Click # 000	224000	EUDAMED	Class I	Active
roeko Wattekügelchen/Cotton Pellets Sample	5172	EUDAMED	Class I	Active
roeko Solomat-Click Refill # 00, 3pcs	214100	EUDAMED	Class I	Active
HANEL OccluFoil+ 12µ 22mm 2sided green PET	60022264	EUDAMED	Class I	Active
roeko Solomat-Click # 1	224111	EUDAMED	Class I	Active
Dental rolls ROEKO Luna #1 500pcs	105001	EUDAMED	Class I	Active
HANEL Articulating paper 200µ strips 18x50 mm blue	480397	EUDAMED	Class I	Active
roeko Solomat-Click # 00	224100	EUDAMED	Class I	Active
roeko GuttaFlow2 Mixing Tips, 24 pcs.	60013719	EUDAMEDFDA UDI	Class I	Active
HANEL Occlusion foil 12µ 80mm 1sided black	480031	EUDAMED	Class I	Active
HANEL Shimstock foil 8 µ 8mm x 5m no colour	480180	EUDAMED	Class I	Active
roeko Comprecap #3, 120 pcs	530010	EUDAMED	Class I	Active
HANEL Articulating paper 80µ I-shaped blue-red	480384	EUDAMED	Class I	Active
HANEL Articulating paper 40µ strips 22x110 mm blue	480357	EUDAMED	Class I	Active
roeko Stay-put / non-impregnated, x-fine (0), 183 cm	521000	EUDAMEDFDA UDI	Class I	Active
roeko GuttaFlow bioseal Refill Applicator	60019561	EUDAMED	Class IIa	Active
HANEL OccluFoil+ 12µ 22mm 2sided black PET	60022262	EUDAMED	Class I	Active
roeko-Swab/pea, 500 pcs.	252001	EUDAMED	Class I	Active
roeko Retracto / twisted / non-impregnated, medium (2), 225 cm	523002	EUDAMEDFDA UDI	Class I	Active
roeko Comprecap anatomic #5, 60 pcs	531205	EUDAMED	Class I	Active
Dental rolls ROEKO Luna Gold # 3/300 g	109123	EUDAMED	Class I	Active
roeko-Swab/hazelnut, 500 pcs.	252002	EUDAMED	Class I	Active
roeko Comprecap #5, 400 pcs	531014	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 80mm 1sided green	480033	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 22mm 2sided black	480041	EUDAMED	Class I	Active
roeko Solomat-N Refill # 000, 6pcs	213000	EUDAMED	Class I	Active
ROEKO Endo-Frost	240000	EUDAMED	Class I	Active
HANEL Occlusion foil 12µ 80mm 2sided red	480052	EUDAMED	Class I	Active
HANEL Articulating paper 80µ C-shaped blue	480377	EUDAMED	Class I	Active
roeko Solomat-Click Refill # 0, 3 pcs	214110	EUDAMED	Class I	Active

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FDA Establishments (1)

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Coltène/Whaledent AG US