Oxford GI Resin CEM UF Handmix

FDA UDI

Class II (US FDA UDI)

by First Scientific Dental Materials GmbH

Identity

Trade Name: Oxford GI Resin CEM UF Handmix FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: Light Cure Ultra Fine Resin Modified Glass Ionomer Cement for Luting FDA UDI
Model / Reference: 51-010 FDA UDI
Description: Light Cure Ultra Fine Resin Modified Glass Ionomer Cement for Luting FDA UDI

Identifiers

Primary DI / UDI-DI: EFSM510100 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glass ionomer dental cement

Oxford GI Resin CEM UF Handmix by First Scientific Dental Materials GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glass ionomer dental cement.

3M™ Ketac™ Fil Plus Aplicap™ — 3M Deutschland GmbH · Class II
KETAC™ — 3M COMPANY · Class II
Ketac™ Cem radiopaque — 3M Deutschland GmbH · Class II
Vitremer™ — 3M COMPANY · Class II
SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
GC Fuji II LC® — Gc America Inc. · 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

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

Manufacturer

Manufacturer: First Scientific Dental Materials GmbH

Sources (1)

FDA UDI 48dd5c61-df1f-4270-9768-a7984111e5c3 35 fields · synced May 31, 2026