Mta Biorep

FDA UDI

Class II (US FDA UDI)

by Itena Clinical

Identity

Trade Name: MTA BIOREP FDA UDI
Generic Name: Hygroscopic dental cement FDA UDI
Model / Reference: Coffret MTA BIOREP 2 patients FDA UDI

Identifiers

Catalog Number: MTA-BRP2.2 FDA UDI
Primary DI / UDI-DI: 03760260220385 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Hygroscopic dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

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: Hygroscopic dental cement

Mta Biorep by Itena Clinical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Itena Clinical

Sources (1)

FDA UDI c9a8aad6-89b1-4c64-91dc-ae8c9f373429 33 fields · synced May 30, 2026