Dental Device Guide
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Manufacturer registered with FDA

FKG Dentaire Sarl

LE CRET-DU-LOCLE, NE, Switzerland. Lists 9 dental device types with FDA across 1 registered establishment.

FDA owner/operator9012284Manufacturer
Device types listed
9
Brands and models
69
510(k) clearances
0as applicant
Markets registered in
14327 registrations outside the US
Establishments
1Switzerland

Registered in 14 markets

Where regulators' registries name FKG Dentaire Sarl as the manufacturer or the registration holder of a device.

All markets
United States: 9 device types listedEuropean Union: 134 registrationsCanada: 46 registrationsSerbia: 32 registrationsUnited Kingdom: 23 registrationsAustralia: 22 registrationsSaudi Arabia: 22 registrationsSouth Korea: 22 registrationsBrazil: 10 registrationsTaiwan: 7 registrationsPeru: 4 registrationsColombia: 2 registrationsCosta Rica: 2 registrationsIsrael: 1 registrations
RegisteredHome: SwitzerlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerFKG Dentaire Sarl9 device types—Below
European UnionEUDAMEDManufacturerFKG Dentaire Sàrl134—Pure Global AI
CanadaHealth CanadaRegistration holderFKG DENTAIRE SARL462017–2026Pure Global AI
SerbiaALIMSManufacturerFKG Dentaire Sarl322024–2026Pure Global AI
United KingdomMHRAManufacturerFKG Dentaire Sàrl23—Pure Global AI
AustraliaTGAManufacturerFKG Dentaire Sarl222023–2025Pure Global AI
Saudi ArabiaSFDAManufacturerFKG Dentaire Sarl22—Pure Global AI
South KoreaMFDSManufacturerFKG Dentaire SarlFKG Dentaire SA · FKG DENTAIRE SA222002–2025Pure Global AI
BrazilANVISAManufacturerFKG DENTAIRE SÀRL102002–2024Pure Global AI
TaiwanTFDAManufacturerFKG DENTAIRE S.A.FKG Dentaire Sàrl · FKG DENTAIRE · +172005–2026Pure Global AI
PeruDIGEMIDManufacturerFKG DENTAIRE S.A.FKG DENTAIRE SARL42012–2017Pure Global AI
ColombiaINVIMAManufacturerFKG DENTAIRE S.A.FKG DENTAIRE SÀRL2—Pure Global AI
Costa RicaMinisterio de SaludManufacturerFKG Dentaire Sàrl2—Pure Global AI
IsraelAMARManufacturerFKG Dentaire Sarl1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What FKG Dentaire Sarl currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
FKGGATESGATES GLIDDENPEESOPEESO DRILLSSHORT GATES
2008
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
FKG
2008
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker
Apical VerifierFKG
2022
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker—2023
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsMaker
FINGER SPREADERSFKGSPREADERS
2008
Endodontic Pulp Canal ReamerEKP · Class 1Endodontic filesMaker
BROACHESEndoSequence Hand FilesFILESFKGHEDSTROMHEDSTROMSK-FILESREAMERSSTIFF K-FILES
2008
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker
FKGPluggers
2020
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesMaker
BC PASTE FILLERBioRaceBT-RaceEdge EvolveEdge X7 UtopiaEdgeDiamond UtopiaEdgeFile X1EdgeFile X3EdgeFile X7EdgeFile XR
35 more
EdgeGlidepathEdgeOne FireEdgeOne GlidepathEdgeOne PlatinumEdgeSequel SapphireEdgeSequel UtopiaEdgeTaperEdgeTaper PlatinumEdgeV-Taper HTEdgeV-Taper HT GlidepathEndoSequence CMEndoSequence CM TaperEndoSequence Orifice ShaperEndoSequence Reciprocating CM FilesEndoSequence Rotary FilesEndoSequence Scout FilesESXFKGPASTE FILLER LENTULORACERazorFlexROOT FILLERSScoutRaceSENSIPASTXP-3D + PROKITXP-3D FinisherXP-3D Finisher RXP-3D Scout FileXP-3D Shaper +XP-4D AssortmentXP-4D LargeXP-4D MediumXP-4D SequenceXP-4D StandardXP-4D Starter
2008
Endodontic BroachEKW · Class 1Endodontic filesMaker
BARBED BROACHES
2008

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
FKG DENTAIRE SARLFDA reg. 9680913LE CRET-DU-LOCLE Neuchatel, SwitzerlandManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9012284). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.