Identity
- Trade Name
- Whitepost System DC 1 Refil EUDAMEDWhitepost System FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- Whitepost System EUDAMEDA system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodontically treated teeth. Whitepost System posts offer retention of direct and indirect materials, allowing for adequate rehabilitation. FDA UDI
- Model / Reference
- 4000055282 EUDAMEDDC 1 Refill FDA UDI
- Description
- A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodontically treated teeth. Whitepost System posts offer retention of direct and indirect materials, allowing for adequate rehabilitation. FDA UDI
Identifiers
- Catalog Number
- 4000055282 FDA UDI
- Primary DI / UDI-DI
- 07899633827114 EUDAMEDFDA UDI
- Basic UDI-DI
- 78996338FGP002Y3 EUDAMED
- FDA Product Code
- ELR FDA UDI
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS EUDAMED
- GMDN Term
- Root canal post, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3810 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Whitepost System DC 1 Refil by Dentscare Ltda — 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 | 78996338FGP002Y3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dentscare Ltda
- EUDAMED SRN
- BR-MF-000004013
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (2)
- EUDAMED 3c463bba-18a9-47b1-b8c7-c0889549eeb0 61 fields · synced Jul 16, 2026
- FDA UDI f0981e41-f648-427f-be4b-ac11130d3c5b 34 fields · synced May 27, 2026