← Back to catalogue

ENDOSEAL MTA(3 g)

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 00000Model ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTA

by Maruchi

Identity

Trade Name
ENDOSEAL MTA(3 g) EUDAMED
ENDOSEAL MTA FDA UDI
Generic Name
Hygroscopic dental cement FDA UDI
Device Name
ENDOSEAL MTA EUDAMED
1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal, including accessory and lateral canals. It is eugenol-free and will not impede adhesion inside the root canal. 2. Principle of operation: The essential principle of operation is that calcium silicate, an ingredient of natural cement in the Endoseal MTA, quickly conducts hydration reactions by absorbing moisture around the mouth and root canals due to hygroscopic materials, and starts to harden. 3. Storage conditions: 1) The product should be stored at room temperature avoiding high temperature and humidity. 2) The product use immediately after replacing the 24 gauge tip because it will be hardened when in contact with air. 3) After using the 24 gauge tip, keep the metal part cut off. A new 24 gauge tip replaces it in next use. 4. Shelf life: 2 years from date of manufacture. FDA UDI
Model / Reference
ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTA EUDAMED
00000 EUDAMED
ENDOSEAL MTA FDA UDI
Description
1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal, including accessory and lateral canals. It is eugenol-free and will not impede adhesion inside the root canal. 2. Principle of operation: The essential principle of operation is that calcium silicate, an ingredient of natural cement in the Endoseal MTA, quickly conducts hydration reactions by absorbing moisture around the mouth and root canals due to hygroscopic materials, and starts to harden. 3. Storage conditions: 1) The product should be stored at room temperature avoiding high temperature and humidity. 2) The product use immediately after replacing the 24 gauge tip because it will be hardened when in contact with air. 3) After using the 24 gauge tip, keep the metal part cut off. A new 24 gauge tip replaces it in next use. 4. Shelf life: 2 years from date of manufacture. FDA UDI

Identifiers

Primary DI / UDI-DI
08800071200000 EUDAMEDFDA UDI
Basic UDI-DI
8800071200000TZ EUDAMED
510(k) Number
K170175 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 EUDAMED
Class II FDA UDI
Regulation Number
872.3820 FDA UDI
Market of Registration
Bulgaria 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

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental coating, tooth-desensitizing

ENDOSEAL MTA(3 g) by Maruchi — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental coating, tooth-desensitizing.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Maruchi
EUDAMED SRN
KR-MF-000030192
Authorised Representative
KTR Europe GmbH DE-AR-000005685

Sources (2)

  • EUDAMED 6c9eb126-784c-46d9-a16a-88cd260401cf 61 fields · synced Jun 18, 2026
  • FDA UDI 6620f431-83d9-4986-9a04-5ed2fd182d0a 35 fields · synced May 30, 2026