← Back to catalogue
Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed
EUDAMEDClass IIa (EU MDR)
Ref C3399-105SPRef CS3399-105RLRef C3399-105RBRef C3399-105RL
Identity
- Trade Name
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed EUDAMEDDisposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed Short EUDAMED
- Device Name
- Dental Prophy Angles EUDAMED
- Model / Reference
- C3399-105SP EUDAMEDCS3399-105RL EUDAMEDC3399-105RB EUDAMEDC3399-105RL EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125C3399105SP2 EUDAMED+D125CS3399105RL2 EUDAMED+D125C3399105RB2 EUDAMED+D125C3399105RL2 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, Ribbed and Webbed 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
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
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 23e98f64-f51d-4750-a059-d496928db3dd 61 fields · synced Jul 30, 2026
- EUDAMED e5293e16-de1d-4854-b6a0-660255f0454b 61 fields · synced May 17, 2026
- EUDAMED 4be4d03e-dc1b-479c-b496-7e587470e149 61 fields · synced May 18, 2026
- EUDAMED 308bfb31-b1a8-49f9-a385-fe3b6d35ccf6 61 fields · synced May 18, 2026