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Disposable Prophy Angles, 105° Contra Angle Clear, Turbine Blade
EUDAMEDClass IIa (EU MDR)
Ref CT3399-105RBRef CT3399-105RLRef 658 600 036 500 060Ref 658 600 036 300 060
Identity
- Trade Name
- Disposable Prophy Angles, 105° Contra Angle Clear, Turbine Blade EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- CT3399-105RB EUDAMEDCT3399-105RL EUDAMED658 600 036 500 060 EUDAMED658 600 036 300 060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125CT3399105RB2 EUDAMED+D125CT3399105RL2 EUDAMED+D1256586000365000602 EUDAMED+D1256586000363000602 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, 105° Contra Angle Clear, Turbine Blade by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED
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Also classified as Dentifrice.
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- 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 5e808959-fef7-4f74-a489-9c5944766be0 61 fields · synced Jul 24, 2026
- EUDAMED a88265e8-cfaf-4f18-a2b0-abf185278c3a 61 fields · synced May 18, 2026
- EUDAMED 4d110181-7892-4f64-ba8f-21bc3a762bd5 61 fields · synced May 18, 2026
- EUDAMED dbc50c29-2038-43b2-afa9-a725e851650e 61 fields · synced May 18, 2026