Cyclone
by On Dent Tibbi Malz. Dis Pro Ith. Ihr. San. ve Tic. Ltd. Sti 127 variants
Ref RZ-10008PRMModel CYCLONE PERMA
Cyclone (RZ-10008PRM) 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-08680445504510), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08680445504510 08680445504510 | Date26 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-08680445504510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Cyclone Resin for 3D Printer
- Model / reference
- CYCLONE PERMA, RZ-10008PRM
- Primary DI / UDI-DI
- 08680445504510
- Basic UDI-DI
- B-08680445504510
- 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
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