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Luzzani LU146 Pro-Tip Converter Kit Cefla
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 116342CEFLA
Identity
- Trade Name
- Luzzani LU146 Pro-Tip Converter Kit Cefla EUDAMEDAstek FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- Luzzani LU146 Pro-Tip Converter Kit Cefla EUDAMEDFDA UDI
- Model / Reference
- 116342CEFLA EUDAMEDFDA UDI
- Description
- Luzzani LU146 Pro-Tip Converter Kit Cefla FDA UDI
Identifiers
- Catalog Number
- 116342CEFLA FDA UDI
- Primary DI / UDI-DI
- 10840326422073 EUDAMED00840326422076 FDA UDI
- Basic UDI-DI
- B-10840326422073 EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Luzzani LU146 Pro-Tip Converter Kit Cefla by Young Innovations, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10840326422073 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 7ecde8e1-0c61-4bf6-ae54-3a6db0fd8fc0 61 fields · synced Jul 28, 2026
- FDA UDI b4069ec9-f65b-4dba-9d15-f0116c7e44bd 35 fields · synced May 30, 2026