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K-Files

by FKG Dentaire Sàrl 42 variants

Ref 01.154.31.080.CG, S1.1B4.00.SAF.FK, S1.1B4.00.0AD.FK, S1.1B4.00.0AT.FK, S1.1B4.00.0AO.FK, S1.1B4.00.0AH.FK, S1.1B4.00.SAB.FK, S1.1B4.00.SAK.FK, S1.1B4.00.SAM.FK, S1.1B4.00.0AE.FK, S1.1B4.00.0AC.FK, S1.1B4.00.SAL.FK, S1.1B4.00.0AZ.FK, S1.1B4.00.0AN.FK, S1.1B4.00.0AI.FK, S1.1B4.00.0AA.FK, S1.1B4.00.0AM.FK, S1.1B4.00.0AS.FK, S1.1B4.00.SAJ.FK, S1.1B4.00.0AK.FK, S1.1B4.00.0BA.FK, S1.1B4.00.0AW.FK, S1.1B4.00.0AQ.FKModel 03.050.31.025.CT

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7640142410301029G Basic UDI-DI Date21 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142416050 UDI-DI Date14 Aug 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Manual endodontic file/rasp, reusable
Device Name
Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment
Barbed Broaches
Model / Ref / Catalog
01.154.31.080.CG, S1.1B4.00.SAF.FK, S1.1B4.00.0AD.FK, 03.050.31.025.CT, S1.1B4.00.0AT.FK, S1.1B4.00.0AO.FK, S1.1B4.00.0AH.FK, S1.1B4.00.SAB.FK, S1.1B4.00.SAK.FK, S1.1B4.00.SAM.FK, S1.1B4.00.0AE.FK, S1.1B4.00.0AC.FK, S1.1B4.00.SAL.FK, S1.1B4.00.0AZ.FK, S1.1B4.00.0AN.FK, S1.1B4.00.0AI.FK, S1.1B4.00.0AA.FK, S1.1B4.00.0AM.FK, S1.1B4.00.0AS.FK, S1.1B4.00.SAJ.FK, S1.1B4.00.0AK.FK, S1.1B4.00.0BA.FK, S1.1B4.00.0AW.FK, S1.1B4.00.0AQ.FK
Primary DI / UDI-DI
07640142416050, 07640142435266, 07640142424246, 07640142424154, 07640142424123, 07640142435228, 07640142412939, 07640142412960, 07640142413424, 07640142424253, 07640142424239, 07640142412977, 07640142435211, 07640142424116, 07640142435235, 07640142424215, 07640142413479, 07640142424147, 07640142412953, 07640142413608, 07640142435242, 07640142424185, 07640142435273
Basic UDI-DI
7640142410301029G, 7640142410301019E
FDA Product Code
EKS
EMDN Code
L159004 Endodontic rasps and files, reusable
GMDN Term
Manual endodontic file/rasp, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
872.4565
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I
SterileEUDAMED
No
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000017925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from FKG Dentaire Sàrl

See all devices from FKG Dentaire Sàrl →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No