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Quadrant Anterior Shine capsule D3
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FA69TModel Quadrant Composites
Identity
- Trade Name
- Quadrant Anterior Shine capsule D3 EUDAMED
- Device Name
- Quadrant Anterior Shine EUDAMED
- Model / Reference
- Quadrant Composites EUDAMEDFA69T EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241FA69T0 EUDAMED
- Basic UDI-DI
- ++E241FA004H EUDAMED
- Direct Marketing DI
- E241FA69T0 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Quadrant Anterior Shine capsule D3 by Cavex Holland BV — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K983549 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E241FA004H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED 9cea97c4-95e0-4e3a-9776-4fee1d0d69e6 61 fields · synced Jun 18, 2026
- FDA 510(k) K983549 1 fields · synced May 18, 2026