Identity
- Trade Name
- DENTA II FDA UDI
- Generic Name
- Dental carbon dioxide laser system FDA UDI
- Device Name
- DENTA II body (DENTA II laser system) FDA UDI
- Model / Reference
- DENTA II body FDA UDI
- Description
- DENTA II body (DENTA II laser system) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447651507 FDA UDI
- 510(k) Number
- K091320 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
No
FDA UDI
Category: Dental carbon dioxide laser system
Denta Ii by Lutronic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental carbon dioxide laser system.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- DEKA SmartXide UltraSpeed 2 — EL.EN. SPA · Class II
- DEKA SmartXide UltraSpeed — EL.EN. SPA · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- LightScalpel — LIGHTSCALPEL INC · Class II
- Solea — CONVERGENT DENTAL · Class II
- Solea — CONVERGENT DENTAL · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA UDI 138d329d-7dd4-43d2-986c-83d925d9c642 36 fields · synced Jun 8, 2026