remanium®

FDA UDI

Class II (US FDA UDI)

by Dentaurum

Identity

Trade Name: remanium® FDA UDI
Generic Name: Dental casting non-noble alloy FDA UDI
Device Name: remanium® 2001 CoCr bonding alloy with balanced price-performance ratio / For further information please visit our online-shop on our website www.dentaurum.de FDA UDI
Model / Reference: 102-600-01 FDA UDI
Description: remanium® 2001 CoCr bonding alloy with balanced price-performance ratio / For further information please visit our online-shop on our website www.dentaurum.de FDA UDI

Identifiers

Primary DI / UDI-DI: J011102600010 FDA UDI
FDA Product Code: EJH FDA UDI
GMDN Term: Dental casting non-noble alloy FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental casting non-noble alloy

remanium® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
Magnum Solare — Mesa Italia S.r.l. · Class IIa
NIRANIUM — CMP INDUSTRIES LLC · Class II

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: Dentaurum

Sources (1)

FDA UDI 89aa8c80-a70a-4d7c-ac24-d0b4399eeeae 35 fields · synced May 30, 2026