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PANAVIA SA Cement Universal Automix Value Pack (Universal (A2))
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #4210-EUModel Cements
Identity
- Trade Name
- PANAVIA SA Cement Universal Automix Value Pack (Universal (A2)) EUDAMED
- Device Name
- PANAVIA SA Cement Universal EUDAMED
- Model / Reference
- Cements EUDAMED#4210-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110802102 EUDAMED
- Basic UDI-DI
- 458211076CementW7 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER 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
PANAVIA SA Cement Universal Automix Value Pack (Universal (A2)) by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
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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 | K120379 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K183537 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076CementW7 | 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 61ab8f4e-3f61-4186-b026-a02bd12f7ee9 61 fields · synced Jul 11, 2026
- FDA 510(k) K120379 1 fields · synced Jun 9, 2026