Dia-Root Bio Mta

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 1003-601Model DIA-ROOT BIO MTA 0.5g

by Diadent Group International

Identity

Trade Name: DIA-ROOT BIO MTA EUDAMEDFDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Device Name: DIA-ROOT BIO MTA EUDAMED
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy. FDA UDI
Model / Reference: DIA-ROOT BIO MTA 0.5g EUDAMEDFDA UDI
1003-601 EUDAMED
Description: DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy. FDA UDI

Identifiers

Catalog Number: 1003-601 FDA UDI
Primary DI / UDI-DI: 08806383565783 EUDAMEDFDA UDI
Basic UDI-DI: B-08806383565783 EUDAMED
88063835RCFMWD EUDAMED
FDA Product Code: KIF FDA UDI
EMDN Code: Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
GMDN Term: Endodontic filling/sealing material FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.3820 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental coating, tooth-desensitizing

Dia-Root Bio Mta by Diadent Group International — Class IIa — FDA_510K, MDR, MDD — 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

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200174	Class IIa	Active
EUDAMED	European Union	CE/MDR	B-08806383565783	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-08806383565783	Class IIa	Active

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Manufacturer

Manufacturer: Diadent Group International
EUDAMED SRN: KR-MF-000023806
Authorised Representative: Diadent Europe B.V. NL-AR-000012597

Sources (4)

EUDAMED b2889364-0bd2-4107-9f09-f7e0afa73a86 61 fields · synced Jun 19, 2026
EUDAMED db272860-3b75-4019-b2ee-efbcbfaef55c 61 fields · synced May 19, 2026
FDA UDI 8287795d-340b-469b-8dad-3953decd5808 35 fields · synced May 30, 2026
FDA 510(k) K200174 1 fields · synced May 18, 2026