Identity
- Trade Name
- DEKA SmartXide UltraSpeed 2 FDA UDI
- Generic Name
- Dental carbon dioxide laser system FDA UDI
- Device Name
- DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch. FDA UDI
- Model / Reference
- M110F1 FDA UDI
- Description
- DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057017760726 FDA UDI
- 510(k) Number
- K172362 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
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
Category: Dental carbon dioxide laser system
DEKA SmartXide UltraSpeed 2 by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental carbon dioxide laser system.
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- Solea — CONVERGENT DENTAL · Class II
- Solea — CONVERGENT DENTAL · Class II
- DEKA SmartXide UltraSpeed — EL.EN. SPA · Class II
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 f96b2ae4-dbea-4f83-9665-92a64d3b6f6e 35 fields · synced Jun 9, 2026