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Prophylaxe-Kit 2 - 10 Instrumente
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1957SOModel 16412Ref 0089SO
Identity
- Trade Name
- Prophylaxe-Kit 2 - 10 Instrumente EUDAMEDProphylaxe Kit EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDProphylaxis Kit FDA UDI
- Model / Reference
- 16412 EUDAMED1957SO EUDAMED0089SO EUDAMEDFDA UDI
- Description
- Prophylaxis Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121957SO1 EUDAMEDE3120089SO1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
Prophylaxe-Kit 2 - 10 Instrumente by Edenta Etablissement — Class IIa — 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 | ++E31216412DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (4)
- EUDAMED b4c1365d-1993-4680-b079-78b69b9fc7db 61 fields · synced Aug 1, 2026
- FDA UDI e50b2630-de82-46df-9d9f-81b621b53c09 33 fields · synced May 30, 2026
- EUDAMED 2ce7281b-f85f-4783-b7c6-092d4e0f6eef 61 fields · synced Jun 20, 2026
- EUDAMED 772080b4-ed8e-429b-ac41-d3c51bc215af 61 fields · synced Aug 1, 2026