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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 2 of 16

Device	Model / Reference	Registries	Class	Status
Edgetaper	ET31ASST	EUDAMED	Class IIa	Active
Edgetaper	ETF325NHS	EUDAMED	Class IIa	Active
Edgetaper	ETF425NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETSX19HTS	EUDAMED	Class IIa	Active
Edgetaper	ETSX19NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFSM31HTS	EUDAMED	Class IIa	Active
Edgetaper	ETS131NHS	EUDAMED	Class IIa	Active
Edgetaper	ETF525NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFPRI31HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF431NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF325HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF125HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFMED25HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFLG25HTS	EUDAMED	Class IIa	Active
EdgeDiamond Utopia	EDU1602V21	FDA UDI	Class I	Active
Edge X7 Ultra	X7U300621S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U200629S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU5007V21	FDA UDI	Class I	Active
Edge X7 Ultra	X7U170629S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7UAsst0425S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU5007V25	FDA UDI	Class I	Active
Edge X7 Ultra	X7U400625S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2007V25	FDA UDI	Class I	Active
Edge X7 Ultra	X7U170429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U350629S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU3507V25	FDA UDI	Class I	Active
Edge X7 Ultra	X7U450429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U250629S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU3007V21	FDA UDI	Class I	Active
Edge X7 Ultra	X7U450621S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDUASST25V	FDA UDI	Class I	Active
Edge X7 Ultra	X7U200621S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU3007V31	FDA UDI	Class I	Active
EdgeDiamond Utopia	EDU2004V31	FDA UDI	Class I	Active
Edge X7 Ultra	X7U350421S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU1602V25	FDA UDI	Class I	Active
EdgeDiamond Utopia	EDUASST31V	FDA UDI	Class I	Active
EdgeDiamond Utopia	EDU3007V25	FDA UDI	Class I	Active
Edge X7 Ultra	X7U300421S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U300625S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U250421S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDUASST21V	FDA UDI	Class I	Active
Edge X7 Ultra	X7U170425S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2004V25	FDA UDI	Class I	Active
Edge X7 Ultra	X7U350429S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U400421S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U170421S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U300425S	FDA UDI	Class I	Unknown
Edge X7 Ultra	X7U450421S	FDA UDI	Class I	Unknown
EdgeDiamond Utopia	EDU2007V21	FDA UDI	Class I	Active

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