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Sirona Sprayvit SE137 Pro-Tip Converter Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 116237ASTEK
Identity
- Trade Name
- Sirona Sprayvit SE137 Pro-Tip Converter Kit EUDAMEDAstek FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- Sirona Sprayvit SE137 Pro-Tip Converter Kit EUDAMEDFDA UDI
- Model / Reference
- 116237ASTEK EUDAMEDFDA UDI
- Description
- Sirona Sprayvit SE137 Pro-Tip Converter Kit FDA UDI
Identifiers
- Catalog Number
- 116237ASTEK FDA UDI
- Primary DI / UDI-DI
- 10840326422035 EUDAMED00840326422038 FDA UDI
- Basic UDI-DI
- B-10840326422035 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
Sirona Sprayvit SE137 Pro-Tip Converter Kit 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-10840326422035 | 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 9dcfc06f-1ac1-40a4-81dc-509c9501348e 61 fields · synced Jun 17, 2026
- FDA UDI 2c21ddb0-2b8e-4da1-a5fe-07a830b52fee 35 fields · synced May 30, 2026