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Kavo KA139 Converter Kit Astek
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 116244ASTEK
Identity
- Trade Name
- Kavo KA139 Converter Kit Astek EUDAMEDAstek FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- Kavo KA139 Converter Kit Astek EUDAMEDFDA UDI
- Model / Reference
- 116244ASTEK EUDAMEDFDA UDI
- Description
- Kavo KA139 Converter Kit Astek FDA UDI
Identifiers
- Catalog Number
- 116244ASTEK FDA UDI
- Primary DI / UDI-DI
- 10840326422059 EUDAMED00840326422052 FDA UDI
- Basic UDI-DI
- B-10840326422059 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
Kavo KA139 Converter Kit Astek 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-10840326422059 | 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 dac08768-8805-4eac-b292-d73d7aed35c2 61 fields · synced Jun 18, 2026
- FDA UDI 7f0e7b75-2635-4240-a9ed-a7fdcc770ed8 35 fields · synced May 30, 2026