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Dental Prophylaxis Powder
EUDAMEDFDA UDIClass I (EU MDR)
Ref PT-X3Model PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7
Identity
- Trade Name
- Dental Prophylaxis Powder EUDAMEDREFINE FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Dental Prophylaxis Powder EUDAMED
- Model / Reference
- PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7 EUDAMEDPT-X3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971560453473 EUDAMEDFDA UDI
- Basic UDI-DI
- 697156045SBPSJ EUDAMED
- Direct Marketing DI
- 06971560453473 EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dental Prophylaxis Powder by Guilin Refine Medical Instrument Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156045SBPSJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012204
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED f231ad4f-36fb-45f1-bedb-be1df73c762e 61 fields · synced Jun 18, 2026
- FDA UDI c8e9fd2c-b210-4308-8b08-d4fadcdac9c0 32 fields · synced May 29, 2026