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Elite Turbo Plus Latex Free Purple Prophy Cup 144 Count
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 053901Model Disposable Prophy Angle
Identity
- Trade Name
- Elite Turbo Plus Latex Free Purple Prophy Cup 144 Count EUDAMEDYoung FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- Elite Turbo Plus Latex Free Purple Prophy Cup 144 Count EUDAMEDYoung Prophy Cup, Latex Free, Soft, Short, Purple Elite Web Cup, Screw Type FDA UDI
- Model / Reference
- 053901 EUDAMEDFDA UDIDisposable Prophy Angle EUDAMED
- Description
- Young Prophy Cup, Latex Free, Soft, Short, Purple Elite Web Cup, Screw Type FDA UDI
Identifiers
- Catalog Number
- 053901 FDA UDI
- Primary DI / UDI-DI
- 10302730539018 EUDAMED00302730539011 FDA UDI
- Basic UDI-DI
- B-10302730539018 EUDAMED03027346938K780752EGSK4 EUDAMED
- FDA Product Code
- EHK FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental polishing cup, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6290 FDA UDI
- Market of Registration
- Sweden EUDAMEDIreland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Elite Turbo Plus Latex Free Purple Prophy Cup 144 Count by Young Dental Manufacturing I, Llc — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-10302730539018 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-10302730539018 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Young Dental Manufacturing I, LLC
- EUDAMED SRN
- US-MF-000027132
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (3)
- EUDAMED 443fdeba-7eda-484a-9b04-f49f304e5809 61 fields · synced Oct 6, 2026
- FDA UDI afe13d73-5bcd-45e2-a077-9440b1f05a16 35 fields · synced May 30, 2026
- EUDAMED 58b3300c-5ff9-44cd-9f91-26d415a97f24 61 fields · synced Jul 9, 2026