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Disposable Prophy Cups, CA Metal Shank, Turbine Blades
EUDAMEDClass IIa (EU MDR)
Ref T-222RARef T-222LVRef T-222LB-20Ref T-222YL-20Ref T-222XARef T-222ORRef T-222WT-20Ref T-222LM-20Ref T-222WTRef T-222PK
Identity
- Trade Name
- Disposable Prophy Cups, CA Metal Shank, Turbine Blades EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- T-222RA EUDAMEDT-222LV EUDAMEDT-222LB-20 EUDAMEDT-222YL-20 EUDAMEDT-222XA EUDAMEDT-222OR EUDAMEDT-222WT-20 EUDAMEDT-222LM-20 EUDAMEDT-222WT EUDAMEDT-222PK EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125T222RA2 EUDAMED+D125T222LV2 EUDAMED+D125T222LB204 EUDAMED+D125T222YL204 EUDAMED+D125T222XA2 EUDAMED+D125T222OR2 EUDAMED+D125T222WT204 EUDAMED+D125T222LM204 EUDAMED+D125T222WT2 EUDAMED+D125T222PK2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYCUPSBS EUDAMED
- Unit of Use DI
- 2 EUDAMED4 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 Cups, CA Metal Shank, Turbine Blades by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++D125PROPHYCUPSBS | 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 (10)
- EUDAMED 36bfb114-e974-489e-9556-c00ebb48b76a 61 fields · synced Jul 22, 2026
- EUDAMED c7290a9f-6cf2-4bea-849b-24060bd4252b 61 fields · synced May 11, 2026
- EUDAMED a4d5a6e9-9bee-475d-a717-18876ea761cc 61 fields · synced May 16, 2026
- EUDAMED 400fd90f-0f6f-48b2-86fe-30b00a1da5b0 61 fields · synced May 16, 2026
- EUDAMED 8c7e5f0c-58e2-4a1e-b2c7-a96bc2200cb0 61 fields · synced May 18, 2026
- EUDAMED 20bb5ea6-74b3-4ca7-82c1-6c93cedbca94 61 fields · synced May 18, 2026
- EUDAMED 09db9b1a-587a-4edc-a04a-716ef160a73d 61 fields · synced May 18, 2026
- EUDAMED cbbf31fd-e074-4140-8c11-924f19246f13 61 fields · synced May 18, 2026
- EUDAMED fe95c013-6a0e-430e-8574-829a13f089c6 61 fields · synced May 18, 2026
- EUDAMED 8ba265ed-4c74-43a7-ad43-c00a67660a22 61 fields · synced May 18, 2026