Identity
- Trade Name
- EMS Threaded Tip KiS-1E EUDAMEDObtura Spartan FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- EMS Threaded Tip KiS-1E EUDAMEDEMS Threaded Tip KiS-1E FDA UDI
- Model / Reference
- 932-011 EUDAMEDFDA UDI
- Description
- EMS Threaded Tip KiS-1E FDA UDI
Identifiers
- Catalog Number
- 932-011 FDA UDI
- Primary DI / UDI-DI
- 10843471100872 EUDAMED00843471100875 FDA UDI
- Basic UDI-DI
- B-10843471100872 EUDAMED
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
EMS Threaded Tip KiS-1E 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-10843471100872 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 3e409f67-c92c-4b4b-8195-91c44a852e07 61 fields · synced Jun 18, 2026
- FDA UDI e11d817f-2d01-4047-a9cb-96ae50977644 35 fields · synced May 30, 2026