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Disposable Prophy Brushes, Plastic Shank, Mini Cup
EUDAMEDClass IIa (EU MDR)
Ref X-P269Ref R-P269Ref S-P269
Identity
- Trade Name
- Disposable Prophy Brushes, Plastic Shank, Mini Cup EUDAMED
- Device Name
- Dental Prophy Brushes EUDAMED
- Model / Reference
- X-P269 EUDAMEDR-P269 EUDAMEDS-P269 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125XP2692 EUDAMED+D125RP2692 EUDAMED+D125SP2692 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, Mini Cup by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
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- Dental City — ICP, INC. · Class I
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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 e4e59265-3d43-4546-af68-80f56fab475e 61 fields · synced Jul 25, 2026
- EUDAMED 2f668cde-cfc0-4bc6-ab26-6dd32ab1762a 61 fields · synced May 18, 2026
- EUDAMED 1f79e012-fe8f-4fc0-ab62-5be0ff7e1045 61 fields · synced May 19, 2026