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Disposable Prophy Angles, 60° Turn Reciprocating, Tapered Brush
EUDAMEDClass IIa (EU MDR)
Ref C3399-60-X261TRef C3399-60-X261TARef C3399-60-R261TRef C3399-60-S261TRef C3399-60-S261TA
Identity
- Trade Name
- Disposable Prophy Angles, 60° Turn Reciprocating, Tapered Brush EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- C3399-60-X261T EUDAMEDC3399-60-X261TA EUDAMEDC3399-60-R261T EUDAMEDC3399-60-S261T EUDAMEDC3399-60-S261TA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125C339960X261T2 EUDAMED+D125C339960X261TA2 EUDAMED+D125C339960R261T2 EUDAMED+D125C339960S261T2 EUDAMED+D125C339960S261TA2 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, Tapered Brush by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED
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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 | ++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 (5)
- EUDAMED 57982bff-e09e-4767-9e38-d0b3caf99398 61 fields · synced Sep 17, 2026
- EUDAMED a6cf5227-7cd5-4d6d-b89c-685fef98b701 61 fields · synced May 17, 2026
- EUDAMED 2fb2dc94-8c76-4832-a033-a155ac233b3d 61 fields · synced May 17, 2026
- EUDAMED 4c3fa511-3c4c-4956-8c56-fb4fb64511f5 61 fields · synced May 18, 2026
- EUDAMED 9a739f32-3380-4abe-824c-aab0d3447a7c 61 fields · synced May 18, 2026