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Planmeca ProMax 3D Plus
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 30016946Ref 30016946
by Planmeca Oy
Identity
- Trade Name
- Planmeca ProMax FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProMax 3D Plus EUDAMEDPlanmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Computed Tomography (CBCT) to produce three-dimensional images of the human teeth, jaws and skull. FDA UDI
- Model / Reference
- 30016946 EUDAMEDProMax 3D Plus FDA UDI
- Description
- Planmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Computed Tomography (CBCT) to produce three-dimensional images of the human teeth, jaws and skull. FDA UDI
Identifiers
- Catalog Number
- 30016946, 30054717, 30054719, 30064041, 30054740, 30054741 FDA UDI
- Primary DI / UDI-DI
- 06430035420483 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430035420135L EUDAMEDB-06430035420483 EUDAMED
- 510(k) Number
- K103689 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - HARDWARE ACCESSORIES EUDAMEDZ11030302 EUDAMED
- GMDN Term
- Stationary panoramic/tomographic 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 ProMax 3D Plus by Planmeca Oy — Class IIb — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060328 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 6430035420135L | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6430035420135L | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (4)
- EUDAMED 38688f5c-e165-470e-8a06-52b58f6265e7 61 fields · synced Jun 19, 2026
- EUDAMED 685fe1f2-be22-4187-a08e-dbff7d37e19a 61 fields · synced May 19, 2026
- FDA UDI 5baee382-0e4e-44d6-9b06-7388b2884f93 35 fields · synced May 30, 2026
- FDA 510(k) K060328 1 fields · synced May 18, 2026