Identity
- Trade Name
- EXPERTsurg LUX FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- This is a medical device.This is a medical device. FDA UDI
- Model / Reference
- 1.008.3500 FDA UDI
- Description
- This is a medical device.This is a medical device. FDA UDI
Identifiers
- Catalog Number
- 1.008.3500 FDA UDI
- Primary DI / UDI-DI
- EKAV100835000 FDA UDI
- 510(k) Number
- K140308 FDA UDI
- FDA Product Code
- EBW FDA UDI
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Category: Dental delivery system
EXPERTsurg LUX by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140308 also covers:
- INTRA LUX S600 LED — KaVo Dental GmbH
- MASTERsurg LUX Wireless — KaVo Dental GmbH
- SM5 — KaVo Dental GmbH
- SURGmatic Head S201 L Pro — KaVo Dental GmbH
- SURGmatic Head S201 XL Pro — KaVo Dental GmbH
- SURGmatic S11 C — KaVo Dental GmbH
- SURGmatic S11 L — KaVo Dental GmbH
- SURGmatic S201 C — KaVo Dental GmbH
- SURGmatic S201 L — KaVo Dental GmbH
- SURGmatic S201 L Pro — KaVo Dental GmbH
- SURGmatic S201 XC — KaVo Dental GmbH
- SURGmatic S201 XL — KaVo Dental GmbH
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KaVo Dental GmbH
Sources (1)
- FDA UDI 8a38b32d-36dd-4d94-a161-8983f17ee200 37 fields · synced Jun 8, 2026