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Cyclone

by On Dent Tibbi Malz. Dis Pro Ith. Ihr. San. ve Tic. Ltd. Sti 127 variants

Ref RZ-05015PRMModel CYCLONE PERMA

Cyclone (RZ-05015PRM) is a Class IIa device made by On Dent Tibbi Malz. Dis Pro Ith. Ihr. San. ve Tic. Ltd. Sti, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-08680445504749), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680445504749 Basic UDI-DI 08680445504749UDI-DIDate26 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Cyclone Resin for 3D Printer
Model / reference
CYCLONE PERMA, RZ-05015PRM
Primary DI / UDI-DI
08680445504749
Basic UDI-DI
B-08680445504749
EMDN code
Q0102050199 Dentistry resins - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000040516

Similar devices in this category

Other devices filed under DENTISTRY RESINS - OTHER.

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Properties

  • Implantable
Other properties (11, all answered No)