Temrex Bitewing Loops

FDA UDI

Class I (US FDA UDI)

by Temrex Corp.

Identity

Trade Name: TEMREX BITEWING LOOPS FDA UDI
Generic Name: Dental x-ray film holder, reusable FDA UDI
Device Name: Dental X-Ray Film Holder FDA UDI
Model / Reference: 2400, 2410 FDA UDI
Description: Dental X-Ray Film Holder FDA UDI

Identifiers

Primary DI / UDI-DI: 00850015110542 FDA UDI
FDA Product Code: EGZ FDA UDI
GMDN Term: Dental x-ray film holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.1905 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental x-ray film holder, reusable

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

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Also classified as Dental x-ray film holder, reusable.

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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 d0006292-1d67-4315-99d4-b187f5ec20fe 33 fields · synced May 31, 2026