Identity
- Trade Name
- Planmeca ProMax FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions. FDA UDI
- Model / Reference
- ProMax 3D Max FDA UDI
- Description
- Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions. FDA UDI
Identifiers
- Catalog Number
- 30003115 FDA UDI
- Primary DI / UDI-DI
- 06430035420513 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- Not 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
Planmeca ProMax by Planmeca Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6fdcd2a1-0c2c-400c-b30b-57478a9092f1 35 fields · synced Jun 8, 2026