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NiTi K Files

by Shenzhen Denco Medical Co., Ltd. 30 variants

Ref CODE32K21NT25Model E32 NiTi K Files 6s 21mm No.25

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

The NiTi K Files are a dental root canal instrument collection developed by Shenzhen Denco Medical Co., Ltd. These instruments feature an Endocrine Disruptor (ED) technology, which is not specified in the provided schema, and have undergone self-testing but no other testing protocols mentioned. The file's specifications include its classification as a Class IIa device according to the International Organization for Standardization (ISO).

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942512505199 Basic UDI-DI 06942512505199UDI-DIDate23 Sep 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Dental Root Canal Instruments Files
Model / Reference
E32 NiTi K Files 6s 21mm No.25, CODE32K21NT25
Primary DI / UDI-DI
06942512505199
Basic UDI-DI
B-06942512505199
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000014271
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Shenzhen Denco Medical Co., Ltd.

See all devices from Shenzhen Denco Medical Co., Ltd. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No