Identity
- Trade Name
- Vittra APS Unique Flow EUDAMED
- Device Name
- Vittra APS Unique Flow EUDAMED
- Model / Reference
- 4000055624 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899633829255 EUDAMED
- Basic UDI-DI
- 78996338RST016AD EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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: Dental composite resin
Vittra APS Unique Flow by Dentscare Ltda — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210231 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232994 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 78996338RST016AD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dentscare Ltda
- EUDAMED SRN
- BR-MF-000004013
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (2)
- EUDAMED 4644f707-ae06-4601-9c67-89335cf42ac4 61 fields · synced Jul 26, 2026
- FDA 510(k) K210231 1 fields · synced May 18, 2026