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Disposable Prophy Brushes, Plastic Shank, Junior Cup
EUDAMEDClass IIa (EU MDR)
Ref X-P298Ref R-P268Ref S-P268
Identity
- Trade Name
- Disposable Prophy Brushes, Plastic Shank, Junior Cup EUDAMED
- Device Name
- Dental Prophy Brushes EUDAMED
- Model / Reference
- X-P298 EUDAMEDR-P268 EUDAMEDS-P268 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125XP2982 EUDAMED+D125RP2682 EUDAMED+D125SP2682 EUDAMED
- Basic UDI-DI
- ++D125PROPHYBRUSHES5P EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dentifrice
Disposable Prophy Brushes, Plastic Shank, Junior Cup by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dentifrice.
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- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
- Omni — Keystone Industries · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D125PROPHYBRUSHES5P | Class IIa | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (3)
- EUDAMED 07b40162-de51-4eb3-ad64-8ed444234031 61 fields · synced Jul 31, 2026
- EUDAMED 011cdce9-ceaa-4894-b41f-7bc7fef83225 61 fields · synced May 17, 2026
- EUDAMED ea870762-0c95-4f33-b87f-9069dda632ec 61 fields · synced May 18, 2026