Identity
- Trade Name
- Planmeca ProMax FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProMax 3D Mid, 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
- ProMax 3D Mid FDA UDI
- Description
- Planmeca ProMax 3D Mid, 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
- 10032016 FDA UDI
- Primary DI / UDI-DI
- 06430035420377 FDA UDI
- 510(k) Number
- K103689 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Stationary panoramic/tomographic dental x-ray system, digital
Planmeca ProMax by Planmeca Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103689 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (1)
- FDA UDI d3bb1157-56d8-459c-afdd-e7041fc9624a 35 fields · synced May 30, 2026