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KATANA Cleaner (Trial)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #3971-EUModel Cleaner
Identity
- Trade Name
- KATANA Cleaner (Trial) EUDAMED
- Model / Reference
- Cleaner EUDAMED#3971-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110799716 EUDAMED
- Basic UDI-DI
- 458211076CleanerDJ EUDAMEDB-04582110799716 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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 appliance fabrication material, ceramic
KATANA Cleaner (Trial) by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 458211076CleanerDJ | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191133 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076CleanerDJ | 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 (3)
- EUDAMED d50ca95f-9179-4867-a05d-87cd66f3ea79 61 fields · synced Jul 29, 2026
- EUDAMED a51511c3-0a7b-44cd-9802-9cd922a5cf15 61 fields · synced May 19, 2026
- FDA 510(k) K191133 1 fields · synced May 18, 2026