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FKG Dentaire Sàrl

Switzerland·CH-MF-000017925

Last updated September 17, 2026

About

Discover how FKG became a leader in innovation. Our General Manager, Didier Devaud, shares his vision and explains how the Swiss microtech valley is an inspiration.

From the manufacturer's own website. Source

What FKG Dentaire Sàrl makes

FKG Dentaire Sàrl manufactures rotary and reciprocating endodontic files and rasps designed for single-use applications. Their product portfolio includes specific instruments such as the EdgeOne Glidepath, EdgeOne Fire, EdgeTaper, EdgeTaper Platinum, and Edge Glidepath.

The company is based in Switzerland and maintains device listings within the EUDAMED and FDA UDI databases. Their products are categorized under Class I and Class IIa regulatory classifications.

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

Frequently asked questions

What type of medical devices does FKG Dentaire Sàrl manufacture?

FKG Dentaire Sàrl specializes in the production of rotary and reciprocating endodontic files and rasps. These instruments are specifically designed for single-use applications in dental procedures. Examples of their product portfolio include the EdgeOne Glidepath, EdgeOne Fire, EdgeTaper, EdgeTaper Platinum, and Edge Glidepath.

Where is FKG Dentaire Sàrl based?

The company is based in Switzerland. This location is significant as the manufacturer operates within the Swiss microtech valley, which serves as a hub for their technical development and innovation processes.

How are the devices from FKG Dentaire Sàrl classified for regulatory purposes?

The devices manufactured by FKG Dentaire Sàrl are categorized under Class I and Class IIa regulatory classifications. These classifications are assigned based on the specific risk profile and intended use of the individual endodontic instruments within their product range.

Which regulatory databases list the devices produced by this manufacturer?

FKG Dentaire Sàrl maintains device listings within the EUDAMED database for the European market and the FDA UDI database for the United States market. These listings ensure that the company's endodontic files and rasps are documented in the appropriate regulatory systems for their respective regions.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Switzerland
Address: 4, Le Crêt-du-Locle, Le Crêt-du-Locle, Switzerland
Website: www.fkg.ch/
LinkedIn: linkedin.com/company/fkg-dentaire
Facebook: facebook.com/FKGDentaire
Email: [email protected]
Phone: +41329242244
PRRC Contact: Laurent Besson
EUDAMED SRN: CH-MF-000017925
FDA FEI Number: —
DUNS Number: —

Catalogue (782)

Page 3 of 16

Device	Model / Reference	Registries	Class	Status
Edge X7 Ultra	X7U250625S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U350621S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U170621S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7UAsst0625S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2004V21	FDA UDI	Class I	Active
Edge X7 Ultra	X7U250429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U400425S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U400429S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2507V21	FDA UDI	Class I	Active
Edge X7 Ultra	X7U450625S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2507V25	FDA UDI	Class I	Active
EdgeDiamond Utopia	EDU2507V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7U450425S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U200625S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U400629S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7UAsst0421S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU3507V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7U200425S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U300429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U170625S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U450629S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U250425S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU3507V21	FDA UDI	Class I	Active
EdgeDiamond Utopia	EDU2007V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7UAsst0621S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU1602V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7U300629S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U200421S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U400621S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U350425S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U200429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U350625S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU5007V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7U250621S	FDA UDI	Class I	Unknown
Endowave	6825-430	EUDAMED	Class IIa	Active
Endowave	6820-835	EUDAMED	Class IIa	Active
K-Files	01.154.21.S15.CG	EUDAMEDFDA UDI	Class I	Active
Finisher R	S1.XB0.00.0BC.FK	EUDAMED	Class IIa	Active
Pluggers	02.110.25.040.CG	EUDAMEDFDA UDI	Class I	Active
Edge X7 Utopia	S1.UB1.00.0BV.EE	EUDAMEDFDA UDI	Class IIa	Active
H-Files	01.153.21.030.CG	EUDAMEDFDA UDI	Class I	Active
Spreaders	02.111.21.025.CG	EUDAMEDFDA UDI	Class I	Active
Race	01.7B0.00.0AO.FK	EUDAMED	Class IIa	Active
H-Files	01.153.31.040.CG	EUDAMEDFDA UDI	Class I	Active
Spreaders	02.111.21.035.CG	EUDAMEDFDA UDI	Class I	Active
K-Files	01.154.25.015.CG	EUDAMEDFDA UDI	Class I	Active
Pluggers	02.110.21.015.CG	EUDAMEDFDA UDI	Class I	Active
Endowave	6831-630	EUDAMED	Class IIa	Active
Lentulo	02.171.29.S25.GM	EUDAMEDFDA UDI	Class IIa	Active
K-Files	01.154.21.030.CG	EUDAMEDFDA UDI	Class I	Active

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