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Classic Elite Flex DPA
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 138912Model Disposable Prophy Angle
Identity
- Trade Name
- Classic Elite Flex DPA EUDAMEDYoung FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- Classic Elite Flex DPA EUDAMEDYoung DPA, Latex Free, Classic Elite Flex, Turbo Plus, Extra Soft, Short, Pink Cup, Screw Type FDA UDI
- Model / Reference
- 138912 EUDAMEDFDA UDIDisposable Prophy Angle EUDAMED
- Description
- Young DPA, Latex Free, Classic Elite Flex, Turbo Plus, Extra Soft, Short, Pink Cup, Screw Type FDA UDI
Identifiers
- Catalog Number
- 138912 FDA UDI
- Primary DI / UDI-DI
- 10302731389124 EUDAMED00302731389127 FDA UDI
- Basic UDI-DI
- B-10302731389124 EUDAMED03027346938K780752EGSK4 EUDAMED
- FDA Product Code
- EGS 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
- 872.4200 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Classic Elite Flex DPA by Young Dental Manufacturing I, Llc — Class IIa — CE/MDR, 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-10302731389124 | 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 b209b27f-0cbe-42dc-93e6-056cc2ab833a 61 fields · synced Oct 7, 2026
- FDA UDI 47fe4291-e319-4c2f-a0a7-7f1a76610755 36 fields · synced May 30, 2026
- EUDAMED d7a25b91-aae2-4fb0-98bb-ffbb7b78a88b 61 fields · synced Jun 19, 2026