Identity
- Trade Name
- Planmeca ProMax FDA UDI
- Generic Name
- Stationary panoramic dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProMax EUDAMEDPlanmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI
- Model / Reference
- 30003107 EUDAMEDProMax 2D FDA UDI
- Description
- Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI
Identifiers
- Catalog Number
- 30003107, 30054725, 30064279, 30054726, 30054738, 30054739, 30054747 FDA UDI
- Primary DI / UDI-DI
- 06430035420452 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035420452 EUDAMED
- 510(k) Number
- K051464 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030302 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 by Planmeca Oy — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430035420452 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06430035420452 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (2)
- EUDAMED 6e55a40c-d817-4fa3-84f9-958f334d769b 61 fields · synced Jul 21, 2026
- FDA UDI 6e42e5c2-66bd-4af0-87cb-8961aaf90c2f 35 fields · synced May 29, 2026