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K-Files Flex

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 01.554.31.010.CG

by FKG Dentaire Sàrl

Identity

Trade Name
K-FILES FLEX EUDAMEDFDA UDI
Generic Name
Manual endodontic file/rasp, single-use FDA UDI
Device Name
K-FILES FLEX EUDAMED
Flex. K-Files 554, 31 mm, # 10, handle SMG FDA UDI
Model / Reference
01.554.31.010.CG EUDAMEDFDA UDI
Description
Flex. K-Files 554, 31 mm, # 10, handle SMG FDA UDI

Identifiers

Catalog Number
01.554.31.010.CG FDA UDI
Primary DI / UDI-DI
07640142417620 EUDAMEDFDA UDI
Basic UDI-DI
B-07640142417620 EUDAMED
FDA Product Code
EKS FDA UDI
EMDN Code
L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
GMDN Term
Manual endodontic file/rasp, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

K-Files Flex by FKG Dentaire Sàrl — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FKG Dentaire Sàrl
EUDAMED SRN
CH-MF-000017925
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED f5096e2f-1273-41f9-9e5d-baa9a2ac6f88 61 fields · synced Jun 18, 2026
  • FDA UDI 006dc0d9-a708-456b-9fbe-35488c8ce8ba 34 fields · synced May 30, 2026