Identity
- Trade Name
- Planmeca Romexis FDA UDI
- Generic Name
- Panoramic/tomographic dental x-ray system application software FDA UDI
- Device Name
- Planmeca Romexis is a modular imaging software for dental and medical use, FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- Planmeca Romexis is a modular imaging software for dental and medical use, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035420254 FDA UDI
- 510(k) Number
- K140713 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Panoramic/tomographic dental x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Panoramic/tomographic dental x-ray system application software
Planmeca Romexis by Planmeca Oy — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (2)
- FDA UDI 5cf20d08-4a18-44f8-b3af-3d78ba51b2a6 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026