← Back to catalogue
Prophylaxe Bürste SC - gelb
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1485SC-100Model 16412
Identity
- Trade Name
- Prophylaxe Bürste SC - gelb EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental-professional prophylaxis brush, single-use FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDProphylaxis brush SC yellow FDA UDI
- Model / Reference
- 16412 EUDAMED1485SC-100 EUDAMEDFDA UDI
- Description
- Prophylaxis brush SC yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121485SC1001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121485SC100101 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental-professional prophylaxis brush, single-use 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Prophylaxe Bürste SC - gelb 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 29dd872d-6198-4ea3-a9e0-82b982e4f9d6 61 fields · synced Jul 16, 2026
- FDA UDI dade6955-1da6-4734-8901-f844a95f4189 33 fields · synced May 29, 2026