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Disposable Prophy Brushes, Screw-In, Flat
EUDAMEDClass IIa (EU MDR)
Ref S-261FRef S-261FARef R-261FRef PD003848
Identity
- Trade Name
- Disposable Prophy Brushes, Screw-In, Flat EUDAMED
- Device Name
- Dental Prophy Brushes EUDAMED
- Model / Reference
- S-261F EUDAMEDS-261FA EUDAMEDR-261F EUDAMEDPD003848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125S261F2 EUDAMED+D125S261FA2 EUDAMED+D125R261F2 EUDAMED+D125FIPD0038482 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, Screw-In, Flat 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
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- 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 (4)
- EUDAMED 22d6393f-f36a-4b19-be4d-0a5db4ce5e56 61 fields · synced Oct 6, 2026
- EUDAMED 4a0471ca-035d-459a-bd32-866bf517ef7f 61 fields · synced May 16, 2026
- EUDAMED 15d67f75-33ea-4481-a427-956083e3b3cc 61 fields · synced May 17, 2026
- EUDAMED 0cf15721-c4cc-42c0-a125-2caf7be534b4 61 fields · synced May 19, 2026