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Disposable Prophy Angles, 60° Turn Reciprocating, Turbine Blade
EUDAMEDClass IIa (EU MDR)
Ref CT3399-60LVRef CT3399-60WTRef CT3399-60GRRef CT3399-60LBRef CT3399-60SARef CT3399-60RA
Identity
- Trade Name
- Disposable Prophy Angles, 60° Turn Reciprocating, Turbine Blade EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- CT3399-60LV EUDAMEDCT3399-60WT EUDAMEDCT3399-60GR EUDAMEDCT3399-60LB EUDAMEDCT3399-60SA EUDAMEDCT3399-60RA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125CT339960LV2 EUDAMED+D125CT339960WT2 EUDAMED+D125CT339960GR2 EUDAMED+D125CT339960LB2 EUDAMED+D125CT339960SA2 EUDAMED+D125CT339960RA2 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, 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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- 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 (6)
- EUDAMED d18424f0-7c75-48c5-93de-44a91a4ad444 61 fields · synced Aug 4, 2026
- EUDAMED ca74c3c3-1bdf-4e4a-ae97-12154ddce803 61 fields · synced May 16, 2026
- EUDAMED 3a31d8e2-5222-4ca6-b70b-02a818bdc4bf 61 fields · synced May 17, 2026
- EUDAMED c9b29584-4615-4eb0-973f-70f0aa1cad4d 61 fields · synced May 18, 2026
- EUDAMED 1e622a6b-ad70-4b6a-be67-c8b578702f8c 61 fields · synced May 19, 2026
- EUDAMED 14994d99-1962-4b45-84ce-42d6b3048fb4 61 fields · synced May 19, 2026