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Disposable Prophy Angles, 60° Turn Reciprocating, Turbine Blade Short
EUDAMEDClass IIa (EU MDR)
Ref CTS3399-60XARef CTS3399-60SARef CTS3399-60LVRef CTS3399-60WTRef CTS3399-60GRRef CTS3399-60YLRef CTS3399-60RD
Identity
- Trade Name
- Disposable Prophy Angles, 60° Turn Reciprocating, Turbine Blade Short EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- CTS3399-60XA EUDAMEDCTS3399-60SA EUDAMEDCTS3399-60LV EUDAMEDCTS3399-60WT EUDAMEDCTS3399-60GR EUDAMEDCTS3399-60YL EUDAMEDCTS3399-60RD EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125CTS339960XA2 EUDAMED+D125CTS339960SA2 EUDAMED+D125CTS339960LV2 EUDAMED+D125CTS339960WT2 EUDAMED+D125CTS339960GR2 EUDAMED+D125CTS339960YL2 EUDAMED+D125CTS339960RD2 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 Short 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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- 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 | ++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 (7)
- EUDAMED 0dd43e00-6a04-4823-a029-a251e4a8ee81 61 fields · synced Aug 4, 2026
- EUDAMED ea07b5c4-f410-4b9c-80f1-edbafff7875e 61 fields · synced May 18, 2026
- EUDAMED 055f6b4f-79e1-4f53-9302-9b0968c329c4 61 fields · synced May 18, 2026
- EUDAMED e5ea89bd-9294-416b-8b11-aa76fb13f20a 61 fields · synced May 18, 2026
- EUDAMED 1019304e-19ab-4a24-86d8-fc6ec72e0399 61 fields · synced May 18, 2026
- EUDAMED 5a3b5fb0-d792-4b7f-a2b7-b4776114c86b 61 fields · synced May 19, 2026
- EUDAMED b7d61e42-bb93-473c-9b44-c69d48295b36 61 fields · synced May 19, 2026