← Back to catalogue
Planmeca ProOne
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 30010469 Ref 30010469
by Planmeca Oy
Identity
- Trade Name
- Planmeca ProOne FDA UDI
- Generic Name
- Stationary panoramic dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProOne EUDAMEDPlanmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. FDA UDI
- Model / Reference
- 30010469 EUDAMEDProOne FDA UDI
- Description
- Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. FDA UDI
Identifiers
- Catalog Number
- 30010469, 30054727, 30054735 FDA UDI
- Primary DI / UDI-DI
- 06430035420322 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035420322 EUDAMED6430035420175U EUDAMED
- 510(k) Number
- K072244 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030302 EUDAMEDZ11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stationary panoramic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Planmeca ProOne by Planmeca Oy — Class IIb — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430035420322 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K072244 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06430035420322 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (4)
- EUDAMED 4f4fc485-ecfe-4597-b067-962e6dc4e122 61 fields · synced Aug 2, 2026
- EUDAMED 9e7c1fe5-6985-45ea-a216-ebc343c33543 61 fields · synced May 18, 2026
- FDA UDI 902d09f3-62da-4b45-ae83-2a9b468c22e6 35 fields · synced May 29, 2026
- FDA 510(k) K072244 1 fields · synced May 18, 2026