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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 (785)

Page 1 of 16

Device	Model / Reference	Registries	Class	Status
Edgeone Glidepath	EOFGP25HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETS125HTS	EUDAMED	Class IIa	Active
Edgetaper	ET25ASST	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF421HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFPRI21HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF521NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETP21ASST	EUDAMED	Class IIa	Active
Edgeone Fire	EOFSM25HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF225HTS	EUDAMED	Class IIa	Active
Edge Glidepath	EGP0221HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF131HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFLG31HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF331NHS	EUDAMED	Class IIa	Active
Edgetaper	ETS121NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF321HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF521HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF131NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF331HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFSM21HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF425HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETS231HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF431HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF121NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETS221HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF221NHS	EUDAMED	Class IIa	Active
Edgeone Glidepath	EOFGP31HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF225NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF531HTS	EUDAMED	Class IIa	Active
Edgeone Fire	EOF21ASSTD	EUDAMED	Class IIa	Active
Edgeone Fire	EOF31ASST	EUDAMED	Class IIa	Active
Edgetaper	ETS231NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFLG21HTS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF221HTS	EUDAMED	Class IIa	Active
Edgetaper	ETS225NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOF25ASSTD	EUDAMED	Class IIa	Active
Edgeone Fire	EOF31ASSTD	EUDAMED	Class IIa	Active
Edgeone Fire	EOFPRI25HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF321NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETF525HTS	EUDAMED	Class IIa	Active
Edgetaper	ETS125NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOF21ASST	EUDAMED	Class IIa	Active
Edgetaper	ETF531NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOF25ASST	EUDAMED	Class IIa	Active
Edgeone Glidepath	EOFGP21HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF121HTS	EUDAMED	Class IIa	Active
Edgetaper	ETF231NHS	EUDAMED	Class IIa	Active
Edgeone Fire	EOFMED21HTS	EUDAMED	Class IIa	Active
Edgetaper	ETS221NHS	EUDAMED	Class IIa	Active
Edgetaper Platinum	ETS131HTS	EUDAMED	Class IIa	Active
Edge Glidepath	EGP0231HTS	EUDAMED	Class IIa	Active

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