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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 6 of 16

Device	Model / Reference	Registries	Class	Status
Xs Gates	03.140.10.601.GC	EUDAMEDFDA UDI	Class IIa	Active
K-Files	01.154.31.060.CG	EUDAMEDFDA UDI	Class I	Active
H-Files	01.153.21.035.CG	EUDAMEDFDA UDI	Class I	Active
H-Files	01.153.25.035.CG	EUDAMEDFDA UDI	Class I	Active
Lentulo	02.171.25.040.GM	EUDAMEDFDA UDI	Class IIa	Active
Matrixes	04.205.00.105.AC	EUDAMED	Class I	Active
Biorace	01.7B0.00.0EY.FK	EUDAMED	Class IIa	Active
Edge Sequel Sapphire	ES06355021ASST	EUDAMED	Class IIa	Active
Edge X7 Utopia	S1.UB1.00.0AR.EE	EUDAMEDFDA UDI	Class IIa	Active
Xs Gates	03.140.10.602.GC	EUDAMEDFDA UDI	Class IIa	Active
Race Evo	S1.7B0.00.0GW.FK	EUDAMED	Class IIa	Active
K-Files Flex	01.754.25.020.CG	EUDAMED	Class I	Active
Pluggers	02.110.21.025.CG	EUDAMEDFDA UDI	Class I	Active
Gates	03.140.19.S16.GC	EUDAMEDFDA UDI	Class IIa	Active
Edge X7 Utopia	S1.UB1.00.0AB.EE	EUDAMEDFDA UDI	Class IIa	Active
K-Files	S1.1B4.00.0AY.FK	EUDAMED	Class I	Active
K-Files Flex	01.554.25.035.CG	EUDAMEDFDA UDI	Class I	Active
Endowave	6831-425	EUDAMED	Class IIa	Active
K-Files	S1.1B4.00.0AF.FK	EUDAMED	Class I	Active
Lentulo	02.171.29.030.GM	EUDAMEDFDA UDI	Class IIa	Active
Race Evo	S1.7B0.00.0GK.FK	EUDAMED	Class IIa	Active
Race Evo	S1.7B0.00.0GV.FK	EUDAMED	Class IIa	Active
K-Files	01.154.25.006.CG	EUDAMEDFDA UDI	Class IIa	Active
K-Files	01.154.21.045.CG	EUDAMEDFDA UDI	Class I	Active
Edgefile X7	X7450425HTS	EUDAMED	Class IIa	Active
K-Files Flex	01.554.31.030.CG	EUDAMEDFDA UDI	Class I	Active
K-Files Flex	01.554.25.030.CG	EUDAMEDFDA UDI	Class I	Active
Race Evo	S1.7B0.00.0DP.FK	EUDAMED	Class IIa	Active
H-Files Flex	01.553.25.S15.CG	EUDAMED	Class I	Active
Biorace	01.7B0.00.SAJ.FK	EUDAMED	Class IIa	Active
H-Files	01.153.21.045.CG	EUDAMEDFDA UDI	Class I	Active
K-Files	01.154.21.006.CG	EUDAMEDFDA UDI	Class IIa	Active
H-Files	01.153.25.070.CG	EUDAMEDFDA UDI	Class I	Active
H-Files Flex	01.753.21.020.CG	EUDAMED	Class I	Active
K-Files	S1.1B4.00.0AL.FK	EUDAMED	Class IIa	Active
K-Files	01.154.21.008.CG	EUDAMEDFDA UDI	Class IIa	Active
Biorace	01.7B0.00.0FJ.FK	EUDAMED	Class IIa	Active
Edge X7 Utopia	S1.UB1.00.0AH.EE	EUDAMEDFDA UDI	Class IIa	Active
Edge X7 Utopia	S1.UB1.00.SAA.EE	EUDAMEDFDA UDI	Class IIa	Active
K-Files Flex	01.554.25.015.CG	EUDAMEDFDA UDI	Class I	Active
K-Files	01.154.31.025.CG	EUDAMEDFDA UDI	Class I	Active
Finisher	S1.XB0.00.0CB.FK	EUDAMED	Class IIa	Active
Race Evo	S1.7B0.00.0HF.FK	EUDAMED	Class IIa	Active
Spreaders	02.111.25.035.CG	EUDAMEDFDA UDI	Class I	Active
Endo Stops	06.010.01.100.RO	EUDAMED	Class I	Active
Barbed Broaches	03.050.31.050.CT	EUDAMEDFDA UDI	Class IIa	Active
Bt-Race	S1.7B0.00.0FF.FK	EUDAMED	Class IIa	Active
BT-Apisafe	S1.6B0.00.0AA.FK	EUDAMED	Class IIa	Active
Edge X7 Utopia	S1.UB1.00.0AD.EE	EUDAMEDFDA UDI	Class IIa	Active
Endo Stops	06.010.00.010.JA	EUDAMED	Class I	Active

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