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Dentac

by Oncu Dental Tibbi Malzeme Sanayi Ve Dis Ticaret Anonim Sirketi 106 variants

Ref DC35430-09

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681942656863 Basic UDI-DI 08681942656863UDI-DIDate17 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Proendo PF3 25mm Nickel Titanium Root Canal File
Model / Reference
DC35430-09
Primary DI / UDI-DI
08681942656863
Basic UDI-DI
B-08681942656863
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022981

Other devices from Oncu Dental Tibbi Malzeme Sanayi Ve Dis Ticaret Anonim Sirketi

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Properties

  • Sterile
  • Reusable

Other properties (9)

  • Implantable: 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