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EUDAMED last updated this device on May 14, 2026
B-06970514910390NITI K-Files is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shenzhen Denco Medical Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970514910390B-06970514910390D-P.03.01-028-02-010-SR-000-00-00(01)06970514910390
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010507ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE1 warning recorded — scroll inside the panel to see all entries.
CW009No certificate specifically references this device's Basic UDI-DI.
Primary placement in Türkiye; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | May 14, 2026 | Still on market |
| Austria | May 14, 2026 | Still on market |
| Belgium | May 14, 2026 | Still on market |
| Bulgaria | May 14, 2026 | Still on market |
| Cyprus | May 14, 2026 | Still on market |
| Czechia | May 14, 2026 | Still on market |
| Germany | May 14, 2026 | Still on market |
| Denmark | May 14, 2026 | Still on market |
| Estonia | May 14, 2026 | Still on market |
| EL | May 14, 2026 | Still on market |
| Spain | May 14, 2026 | Still on market |
| Finland | May 14, 2026 | Still on market |
| France | May 14, 2026 | Still on market |
| Croatia | May 14, 2026 | Still on market |
| Hungary | May 14, 2026 | Still on market |
| Ireland | May 14, 2026 | Still on market |
| Iceland | May 14, 2026 | Still on market |
| Italy | May 14, 2026 | Still on market |
| Liechtenstein | May 14, 2026 | Still on market |
| Lithuania | May 14, 2026 | Still on market |
| Luxembourg | May 14, 2026 | Still on market |
| Latvia | May 14, 2026 | Still on market |
| Malta | May 14, 2026 | Still on market |
| Netherlands | May 14, 2026 | Still on market |
| Norway | May 14, 2026 | Still on market |
| Poland | May 14, 2026 | Still on market |
| Portugal | May 14, 2026 | Still on market |
| Romania | May 14, 2026 | Still on market |
| Sweden | May 14, 2026 | Still on market |
| Slovenia | May 14, 2026 | Still on market |
| Slovakia | May 14, 2026 | Still on market |
| XI | May 14, 2026 | Still on market |
CN-MF-000014271No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.DD60147804001