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ENDOCEM PREMIXED REGULAR(2 g)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 00291Model ENDOCEM MTA PREMIXED REGULAR / SendoCem MTA
by Maruchi
Identity
- Trade Name
- ENDOCEM PREMIXED REGULAR(2 g) EUDAMEDENDOCEM MTA PREMIXED REGULAR FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- ENDOCEM MTA PREMIXED REGULAR EUDAMEDENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. It is designed to prevent irritation of pulp and secondary infections. ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal. The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage. FDA UDI
- Model / Reference
- ENDOCEM MTA PREMIXED REGULAR / SendoCem MTA EUDAMED00291 EUDAMEDENDOCEM MTA PREMIXED REGULAR FDA UDI
- Description
- ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. It is designed to prevent irritation of pulp and secondary infections. ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal. The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800071200291 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800071200130UF EUDAMED
- 510(k) Number
- K213757 FDA UDI
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental coating, tooth-desensitizing
ENDOCEM PREMIXED REGULAR(2 g) by Maruchi — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K213757 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8800071200130UF | 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 b2cee461-5c56-40c1-a4c1-6dde9b63b27f 61 fields · synced Jul 16, 2026
- FDA UDI e86e8d37-5d4e-4e0b-b8df-4c573d27e927 35 fields · synced May 30, 2026
- FDA 510(k) K213757 1 fields · synced May 18, 2026