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White ENDOSEAL MTA(2 g)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 00321Model White ENDOSEAL MTA / White ENDOSEAL Bioceramic Sealer / AH Plus® Bioceramic Sealer / VDW.1 Seal™ Bioceramic Sealer
by Maruchi
Identity
- Trade Name
- White ENDOSEAL MTA(2 g) EUDAMED
- Device Name
- White ENDOSEAL MTA EUDAMED
- Model / Reference
- White ENDOSEAL MTA / White ENDOSEAL Bioceramic Sealer / AH Plus® Bioceramic Sealer / VDW.1 Seal™ Bioceramic Sealer EUDAMED00321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071200321 EUDAMED
- Basic UDI-DI
- 8800071200093V2 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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 coating, tooth-desensitizing
White ENDOSEAL MTA(2 g) by Maruchi — 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
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 | K202015 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212229 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8800071200093V2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maruchi
- EUDAMED SRN
- KR-MF-000030192
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 6ef326bd-4664-4702-a54d-c4a11173ebec 61 fields · synced Jun 19, 2026
- FDA 510(k) K202015 1 fields · synced May 18, 2026