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Quadrant Universal LC capsule A3.5
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FU63Model Quadrant Composites
Identity
- Trade Name
- Quadrant Universal LC capsule A3.5 EUDAMED
- Device Name
- Quadrant Universal LC EUDAMED
- Model / Reference
- Quadrant Composites EUDAMEDFU63 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241FU630 EUDAMED
- Basic UDI-DI
- ++E241FU007M EUDAMED
- Direct Marketing DI
- E241FU630 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
Category: Dental composite resin
Quadrant Universal LC capsule A3.5 by Cavex Holland BV — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984041 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E241FU007M | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED 3dba626a-e652-4f57-a9fa-bf5791e1eb23 61 fields · synced Jun 19, 2026
- FDA 510(k) K984041 1 fields · synced May 18, 2026