← Back to catalogue
Disposable Prophy Cups, CA Plastic Shank, Ribbed & Webbed Standard
EUDAMEDClass IIa (EU MDR)
Ref P222ORRef P222GRRef P222XARef P222DBRef P222PKRef P222YLRef P222LB
Identity
- Trade Name
- Disposable Prophy Cups, CA Plastic Shank, Ribbed & Webbed Standard EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- P222OR EUDAMEDP222GR EUDAMEDP222XA EUDAMEDP222DB EUDAMEDP222PK EUDAMEDP222YL EUDAMEDP222LB EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125P222OR2 EUDAMED+D125P222GR2 EUDAMED+D125P222XA2 EUDAMED+D125P222DB2 EUDAMED+D125P222PK2 EUDAMED+D125P222YL2 EUDAMED+D125P222LB2 EUDAMED
- Basic UDI-DI
- ++D125PROPHYCUPSBS 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 Cups, CA Plastic Shank, Ribbed & Webbed Standard 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 | ++D125PROPHYCUPSBS | 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 (7)
- EUDAMED 76587edd-afd0-4f53-9266-665ce135a6d2 61 fields · synced Aug 2, 2026
- EUDAMED 77644a35-a5b8-4faf-bfda-00843dc71ca4 61 fields · synced May 17, 2026
- EUDAMED 0ffc4f84-0bd5-4758-8ee6-ea66bffa700d 61 fields · synced May 17, 2026
- EUDAMED f0ea9495-d9f7-43c4-9513-d17e96de6148 61 fields · synced May 18, 2026
- EUDAMED a8401e20-b529-4e1e-8121-5ea91da2de18 61 fields · synced May 18, 2026
- EUDAMED 66faec2f-c1d5-49c2-b121-3bfe84936f3e 61 fields · synced May 18, 2026
- EUDAMED 467088a8-51e1-401f-95ea-6d8c8d9d7385 61 fields · synced May 18, 2026