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Sign in to claim this brandPlanmeca Oy
Finland·FI-MF-000006499
Last updated September 17, 2026
Information
- Country
- Finland
- Address
- 6, Asentajankatu , Helsinki, Finland
- Website
- planmeca.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Tuomas Jurvanen
- EUDAMED SRN
- FI-MF-000006499
- FDA FEI Number
- 1000207287
- DUNS Number
- 368788568
Catalogue (67)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Planmeca ProMax | ProMax 3D Max | FDA UDI | Class II | Unknown |
| Planmeca Sovereign | Classic | FDA UDI | Class I | Unknown |
| Planmeca Chair | Chair | FDA UDI | Class I | Unknown |
| Planmeca ProMax | ProMax 3D | FDA UDI | Class II | Active |
| Planmeca ProMax | ProMax 3D Plus | FDA UDI | Class II | Active |
| Planmeca Viso | G5 | FDA UDI | Class II | Active |
| Planmeca ProMax | ProMax 3D Mid | FDA UDI | Class II | Active |
| Planmeca Viso | G7 | FDA UDI | Class II | Active |
| Planmeca ProMax | ProMax 3D Max | FDA UDI | Class II | Unknown |
| Planmeca Romexis | 4 | FDA UDI | Class II | Active |
| Planmeca ProMax | ProMax 3D | FDA UDI | Class II | Unknown |
| Planmeca ProMax | ProMax 3D | FDA UDI | Class II | Unknown |
| Planmeca ProMax | ProMax 3D Max | FDA UDI | Class II | Unknown |
| Planmeca ProMax | ProMax 2D | FDA UDI | Class II | Active |
| Planmeca Emerald S | 30018474 | EUDAMED | Class I | Active |
| Planmeca Emerald | 30006359 | EUDAMED | Class I | Active |
| Planmeca Compact i5 | 30013450 | EUDAMEDFDA UDI | Class IIa | Active |
| Planmeca Viso 2D Classic | 30051739 | EUDAMED | Class IIb | Active |
| KaVo ProXam 2D | 30038581 | EUDAMED | Class IIb | Active |
| Planmeca Olo | 10033200 | EUDAMED | Class I | Active |
| KaVo ProXam iX | 30038579 | EUDAMED | Class IIb | Active |
| Planmeca Pro50 Chair | 30011796 | EUDAMEDFDA UDI | Class I | Active |
| Pm 2002 Cc Proline | K970812 | FDA 510(k) | Class II | Active |
| Dixi 2 | K000428 | FDA 510(k) | Class II | Active |
| Planmeca Intracam | K972033 | FDA 510(k) | Class I | Active |
| Promax, Panoramic X-Ray Unit With Cephalostat | K011619 | FDA 510(k) | Class II | Active |
| Prostyle Intra | K970975 | FDA 510(k) | Class II | Active |
| Pm 2002 Proline/Aec | K000163 | FDA 510(k) | Class II | Active |
| Prostyle Compact | K961420 | FDA 510(k) | Class I | Active |
| Planmeca ProMax 3D Max, Planmeca Maximity | K160506 | FDA 510(k) | Class II | Active |
| Dimex 2 | K000454 | FDA 510(k) | Class II | Active |
| Prostyle Compact | K963209 | FDA 510(k) | Class I | Active |
| Planmeca Dixi, Digital Intraoral X-Ray Imaging System | K980581 | FDA 510(k) | Class II | Active |
| Pm 2002 Cc Proline | K970263 | FDA 510(k) | Class II | Active |
| Planmeca Intracam Station | K984013 | FDA 510(k) | Class I | Active |
| Panoramic X-Ray Units, Modification | K934063 | FDA 510(k) | Class II | Active |
| Planmeca Promax 3d Max | K093590 | FDA 510(k) | Class II | Active |
| Panoramic X-Ray Unit (modification) | K952763 | FDA 510(k) | Class II | Active |
| Planmeca Promax With Dec (dynamic Exposure Control) | K051464 | FDA 510(k) | Class II | Active |
| Prostyle Intra | K955429 | FDA 510(k) | Class II | Active |
| Dimax 2 | K000771 | FDA 510(k) | Class II | Active |
| Planmeca SingLED | 10020815 | EUDAMEDFDA UDI | Class I | Active |
| Planmeca ProMax | 30003108 | EUDAMEDFDA UDI | Class IIb | Active |
| Planmeca Solanna | 30009016 | EUDAMEDFDA UDI | Class I | Active |
| Planmeca Lumo | 10033600 | EUDAMED | Class I | Active |
| Planmeca ProOne | 30010469 | EUDAMEDFDA UDI | Class IIb | Active |
| Planmeca Imprex | 30031809 | EUDAMED | Class I | Active |
| Planmeca ProMax | 30003107 | EUDAMEDFDA UDI | Class IIb | Active |
| Planmeca Compact i EMS | 30022989 | EUDAMED | Class I | Active |
| Planmeca Viso G5 | 30048120 | EUDAMEDFDA UDI | Class IIb | Active |
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