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ENDOSEAL MTA(2 g)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 04312Model ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTARef 00307
by Maruchi
Identity
- Trade Name
- ENDOSEAL MTA(2 g) EUDAMED
- Device Name
- ENDOSEAL MTA EUDAMED
- Model / Reference
- ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTA EUDAMED04312 EUDAMED00307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071204312 EUDAMED08800071200307 EUDAMED
- Basic UDI-DI
- 8800071200000TZ EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
ENDOSEAL MTA(2 g) by Maruchi — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K133054 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K170175 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8800071200000TZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maruchi
- EUDAMED SRN
- KR-MF-000030192
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 95b3d99b-597d-4a2c-8c46-d26bb3456140 61 fields · synced Jul 21, 2026
- EUDAMED f7d0b7b9-b610-4583-88df-92516b218747 61 fields · synced May 19, 2026
- FDA 510(k) K133054 1 fields · synced May 18, 2026