Temrex Cr Plus

FDA UDI

Class I (US FDA UDI)

by Temrex Corp.

Identity

Trade Name: TEMREX CR PLUS FDA UDI
Generic Name: Zinc oxide eugenol dental cement FDA UDI
Device Name: DENTAL CEMENT FDA UDI
Model / Reference: 7790 KIT FDA UDI
Description: DENTAL CEMENT FDA UDI

Identifiers

Primary DI / UDI-DI: 00850015110047 FDA UDI
FDA Product Code: EMB FDA UDI
GMDN Term: Zinc oxide eugenol dental cement FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3275 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Zinc oxide eugenol dental cement

Temrex Cr Plus by Temrex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TempoLok NE Cement 2x5ml syringe, 20 mixing tips — Sterngold Dental LLC · Class II
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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 I	Pending data

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Manufacturer

Manufacturer: Temrex Corp.

Sources (1)

FDA UDI 395730b6-5131-400c-8b58-97afe0f79724 33 fields · synced May 29, 2026