Identity
- Trade Name
- DEKA SMARTFILE FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- The Smartfile medical system is a Nd:YAG laser device for treatment of dental desease. The laser radiation is delivered to the treatment area through the handpieces. FDA UDI
- Model / Reference
- M077C2 FDA UDI
- Description
- The Smartfile medical system is a Nd:YAG laser device for treatment of dental desease. The laser radiation is delivered to the treatment area through the handpieces. FDA UDI
Identifiers
- Catalog Number
- M077C2 FDA UDI
- Primary DI / UDI-DI
- 08057017760054 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
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
Moist Heat or Steam Sterilization FDA UDI
Deka Smartfile by El.en. Spa — 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
- El.en. Spa
Sources (1)
- FDA UDI d98fb9f1-887f-4638-97c4-a806a6a9b3d7 36 fields · synced Jun 9, 2026