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CLEARFIL MAJESTY ES Flow Universal Super Low (UD) TRIAL
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #4623-EUModel Composites510(k) K191980Ref #4621-EU
Identity
- Trade Name
- CLEARFIL MAJESTY ES Flow Universal Super Low (UD) TRIAL EUDAMEDCLEARFIL MAJESTY ES Flow Universal Super Low (UD) EUDAMED
- Model / Reference
- Composites EUDAMED#4623-EU EUDAMED#4621-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110806230 EUDAMED04582110806216 EUDAMED
- Basic UDI-DI
- 458211076CompositeKS 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 ES Flow Universal Super Low (UD) TRIAL by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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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 | K191980 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K130371 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076CompositeKS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- FDA Applicant
- Kuraray Noritake Dental, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2073efc6-2714-448b-b057-7a366b6ab24e 85 fields · synced Jul 9, 2026
- EUDAMED fc927bc9-6e86-4c45-bc15-05246bb96fd4 61 fields · synced May 17, 2026
- FDA 510(k) K191980 1 fields · synced May 18, 2026