Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680913

FEI Number

3006610063

Entity Name

FKG DENTAIRE SARL

City/State/Country

LE CRET-DU-LOCLE Neuchatel, CH

Establishment Address

LE CRET-DU-LOCLE 4, LE CRET-DU-LOCLE Neuchatel CH-2322, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

F K G DENTAIRE SARL (Owner Number: 9012284)

Owner / Operator Contact Address

LE CRET-DU-LOCLE 4, --, LE CRET-DU-LOCLE, NE, CH-NE CH-2322, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EndoSequence Scout Files EndoSequence Orifice Shaper XP-4D Sequence RACE XP-4D Standard PASTE FILLER LENTULO XP-3D Shaper + XP-3D Scout File EdgeSequel Utopia FKG EdgeOne Glidepath EdgeGlidepath RazorFlex ESX ScoutRace BC PASTE FILLER XP-4D Medium EndoSequence Reciprocating CM Files Edge X7 Utopia BT-Race SENSIPAST XP-4D Large XP-4D Assortment XP-3D Finisher BioRace EdgeFile X3 XP-3D Finisher R XP-4D Starter EdgeTaper Platinum XP-3D + PROKIT EdgeOne Fire EdgeTaper EdgeFile X7 EndoSequence CM Taper EdgeDiamond Utopia ROOT FILLERS EndoSequence Rotary Files EndoSequence CM EdgeSequel Sapphire PEESO FKG PEESO DRILLS SHORT GATES GATES GATES GLIDDEN BARBED BROACHES SPREADERS FINGER SPREADERS FKG FKG FILES K-FILES HEDSTROM STIFF K-FILES BROACHES REAMERS EndoSequence Hand Files HEDSTROMS FKG Apical Verifier FKG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2023-09-06
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2008-06-02
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2008-06-02
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2008-06-02
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2008-06-02
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2008-06-02
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2022-11-16
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Nate Thomas Business: Brasseler U.S.A. Dental, LLC Email: nate.thomas@henryschein.com Phone: (801) 4199689

Related Public Records

Same Entity

F K G DENTAIRE SARL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

Registration Number	Establishment Name	Location
8040233	QSA SURGICAL (PVT) LTD.	SIALKOT Punjab, PK
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
3003877407	ZAIN'S MEDICAL IMAGE	SIALKOT Punjab, PK
3014953747	FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.	Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680913. Last updated year: 2026. Please use registration number 9680913 when referencing this establishment in official correspondence.