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KATANA AVENCIA Block 2 14L/A3.5 ML
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #4184-EUModel Blocks
Identity
- Trade Name
- KATANA AVENCIA Block 2 14L/A3.5 ML EUDAMED
- Model / Reference
- Blocks EUDAMED#4184-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110801846 EUDAMED
- Basic UDI-DI
- 458211076BlockMH EUDAMED
- EMDN Code
- Q01020602 COMBINED DENTAL PROSTHESES 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
KATANA AVENCIA Block 2 14L/A3.5 ML by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K153476 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076BlockMH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fa741999-79dd-4451-becc-39619d9073e2 61 fields · synced Jul 13, 2026
- FDA 510(k) K153476 1 fields · synced May 18, 2026