Temrex Matrix Retainer

FDA UDI

Class I (US FDA UDI)

by Temrex Corp.

Identity

Trade Name: TEMREX MATRIX RETAINER FDA UDI
Generic Name: Dental matrix band retainer FDA UDI
Device Name: A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. FDA UDI
Model / Reference: 97, 98, 99, 100, 101 FDA UDI
Description: A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850015110627 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Dental matrix band retainer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

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

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Dental matrix band retainer

Temrex Matrix Retainer by Temrex Corp. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Temrex Corp.

Sources (1)

FDA UDI 9c401686-cc3b-413b-922a-df24986bc988 33 fields · synced May 31, 2026