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CLEARFIL MAJESTY Flow (Cv)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #2621-EUModel Composites
Identity
- Trade Name
- CLEARFIL MAJESTY Flow (Cv) EUDAMED
- Model / Reference
- Composites EUDAMED#2621-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110786211 EUDAMED
- Basic UDI-DI
- 458211076Composite132Z5 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
CLEARFIL MAJESTY Flow (Cv) by Kuraray Noritake Dental Inc. Kurashiki — 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 | K121583 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076Composite132Z5 | 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 0d97b3be-9e9a-4fa8-883d-e7099f4e84bb 61 fields · synced Jul 17, 2026
- FDA 510(k) K121583 1 fields · synced May 18, 2026