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Arabesk Top
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 1530Ref 1556Ref 1534Ref 1549Ref 1548Ref 1535Ref 1533Ref 1537
by VOCO GmbH
Identity
- Trade Name
- Arabesk Top EUDAMED
- Device Name
- Arabesk Top EUDAMED
- Model / Reference
- 1530 EUDAMED1556 EUDAMED1534 EUDAMED1549 EUDAMED1548 EUDAMED1535 EUDAMED1533 EUDAMED1537 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22115301 EUDAMEDE22115561 EUDAMEDE22115341 EUDAMEDE22115491 EUDAMEDE22115481 EUDAMEDE22115351 EUDAMEDE22115331 EUDAMEDE22115371 EUDAMED
- Basic UDI-DI
- ++E2210057000000000D7 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Arabesk Top by VOCO GmbH — 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 | K994268 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210057000000000D7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (10)
- EUDAMED 3826c300-ec30-4733-8b61-13ee96d516f7 61 fields · synced Jul 24, 2026
- EUDAMED 3469245e-2e79-41e2-9431-00b8cb425253 61 fields · synced Jul 8, 2026
- EUDAMED cfb42db6-7bb1-4b0d-b4cb-755c5b609427 61 fields · synced Jul 8, 2026
- EUDAMED 24559647-8ff6-42b9-9370-a11053a2bc75 61 fields · synced Jul 13, 2026
- EUDAMED 996b0804-4404-427e-81f6-c28df213d80f 61 fields · synced Jul 18, 2026
- EUDAMED 956098d1-9b8b-432b-b540-c2dd05c631e0 61 fields · synced Jul 19, 2026
- EUDAMED c52a80d3-19db-4831-92cd-dc0d38bca218 61 fields · synced Jul 20, 2026
- EUDAMED 057e9efe-cfeb-4d9d-a802-673849cb5b34 61 fields · synced Jul 21, 2026
- EUDAMED 34d40b3e-5f88-4dc1-a3f8-feea455db24f 61 fields · synced Jul 24, 2026
- FDA 510(k) K994268 1 fields · synced May 18, 2026