Identity
- Trade Name
- Planmeca SingLED FDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- Planmeca SingLED EUDAMEDPlanmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology. FDA UDI
- Model / Reference
- 10020815 EUDAMEDSingLED FDA UDI
- Description
- Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology. FDA UDI
Identifiers
- Catalog Number
- 10020815 FDA UDI
- Primary DI / UDI-DI
- 06430035420247 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430035420045K EUDAMED
- 510(k) Number
- K923462 FDA UDI
- 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
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 SingLED 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 | 6430035420045K | 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 682ddec4-d694-4559-adab-9c251b6779dd 61 fields · synced Jun 18, 2026
- FDA UDI 3ca667aa-d1f1-415f-a27c-c1babcd5eb79 35 fields · synced May 30, 2026