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Disposable Prophy Angles, 60° Turn Reciprocating, Flat Brush
EUDAMEDClass IIa (EU MDR)
Ref C3399-60-S261FARef C3399-60-R261FARef C3399-60-S261FRef C3399-60-X261F
Identity
- Trade Name
- Disposable Prophy Angles, 60° Turn Reciprocating, Flat Brush EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- C3399-60-S261FA EUDAMEDC3399-60-R261FA EUDAMEDC3399-60-S261F EUDAMEDC3399-60-X261F EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125C339960S261FA2 EUDAMED+D125C339960R261FA2 EUDAMED+D125C339960S261F2 EUDAMED+D125C339960X261F2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYANGLESTN 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 Angles, 60° Turn Reciprocating, Flat Brush by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · 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 | ++D125PROPHYANGLESTN | 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 9f03241f-f2d1-4d26-afc4-e97300079074 61 fields · synced Jul 30, 2026
- EUDAMED 9d872f8f-ed48-43ba-b228-ca9b55224b54 61 fields · synced May 18, 2026
- EUDAMED b153cf6e-48eb-45e7-8f65-d5a0845f30e7 61 fields · synced May 18, 2026
- EUDAMED c178aea3-466e-40de-aa00-32233cf3a52d 61 fields · synced May 19, 2026