Identity
- Trade Name
- Planmeca Solanna FDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- Planmeca Solanna EUDAMEDThe Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position. The exceptionally long arm enables optimal working conditions for operations of all kinds. FDA UDI
- Model / Reference
- 30009016 EUDAMEDSolanna FDA UDI
- Description
- The Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position. The exceptionally long arm enables optimal working conditions for operations of all kinds. FDA UDI
Identifiers
- Catalog Number
- 30006329; 30009016 FDA UDI
- Primary DI / UDI-DI
- 06430035420544 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430035420055M EUDAMED
- FDA Product Code
- EAZ FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- LED dental light, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4630 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Planmeca Solanna by Planmeca Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6430035420055M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (2)
- EUDAMED 9eb7a79a-4e13-4cd8-a43e-f5b9f16ac334 61 fields · synced Jun 18, 2026
- FDA UDI 6ec15b9d-c7b7-4652-bdf0-04206ad43943 34 fields · synced May 30, 2026