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Disposable Prophy Angles, 90° Right Angle Clear, Ribbed and Webbed
EUDAMEDClass IIa (EU MDR)
Ref C3399-090RBRef CS3399-090RBRef 3399-090SGRef CS3399-090SGRef C3399-090SG
Identity
- Trade Name
- Disposable Prophy Angles, 90° Right Angle Clear, Ribbed and Webbed EUDAMEDDisposable Prophy Angles, 90° Right Angle Clear, Ribbed and Webbed Short EUDAMEDDisposable Prophy Angles, 90° Right Angle, Ribbed and Webbed EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- C3399-090RB EUDAMEDCS3399-090RB EUDAMED3399-090SG EUDAMEDCS3399-090SG EUDAMEDC3399-090SG EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125C3399090RB2 EUDAMED+D125CS3399090RB2 EUDAMED+D1253399090SG2 EUDAMED+D125CS3399090SG2 EUDAMED+D125C3399090SG2 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, 90° Right Angle Clear, Ribbed and Webbed 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 (5)
- EUDAMED bbff437d-97c3-4d5f-bc86-f0dc1c12e94f 61 fields · synced Aug 3, 2026
- EUDAMED 8a5b5bd3-c167-4bdd-b501-915ba9b4fed2 61 fields · synced May 17, 2026
- EUDAMED 6c26f2df-8652-47e5-b431-80552a7f9396 61 fields · synced May 17, 2026
- EUDAMED b70057ba-7094-4790-b3d0-f2ba443bca85 61 fields · synced May 18, 2026
- EUDAMED 150b225a-5071-4cc4-b444-207c491de78a 61 fields · synced May 19, 2026