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Temrex Cr

FDA UDI

Class II (US FDA UDI)

by Temrex Corp.

Identity

Trade Name
TEMREX CR FDA UDI
Generic Name
Zinc polycarboxylate dental cement FDA UDI
Device Name
DENTAL CEMENT FDA UDI
Model / Reference
7780 FDA UDI
Description
DENTAL CEMENT FDA UDI

Identifiers

Primary DI / UDI-DI
00850015110078 FDA UDI
510(k) Number
K051952 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Zinc polycarboxylate 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Zinc polycarboxylate dental cement

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

Similar devices

Also classified as Zinc polycarboxylate dental cement.

Cleared under the same submission

K051952 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Temrex Corp.

Sources (1)

  • FDA UDI a44954df-158e-41db-802e-dd022095748a 34 fields · synced May 30, 2026