EUDAMED device

Dental Root Canal Files

EUDAMED device 00810190263006 · TiaDent Inc

Key facts

Primary DI 00810190263006
Device name Dental Root Canal Files
Reference or catalog number TKNI.25.030
Model TK.21.006、TK.25.006、TK.31.006、TK.21.008、TK.25.008、TK.31.008、TK.21.010、TK.25.010、TK.31.010、TK.21.015、TK.25.015、TK.31.015、TK.21.020、TK.25.020、TK.31.020、TK.21.025、TK.25.025、TK.31.025、TK.21.030、TK.25.030、etc
Manufacturer TiaDent Inc
Manufacturer SRN US-MF-000049704
Risk class Class I
EMDN code Q010507
EMDN description ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Oct 22, 2025

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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