Zirlux

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Zirlux FDA UDI
Generic Name: Dental casting non-noble alloy FDA UDI
Device Name: Zirlux TI 98.5x15mm Disc FDA UDI
Model / Reference: 9009526 FDA UDI
Description: Zirlux TI 98.5x15mm Disc FDA UDI

Identifiers

Catalog Number: 9009526 FDA UDI
Primary DI / UDI-DI: H65890095260 FDA UDI
FDA Product Code: EJH FDA UDI
GMDN Term: Dental casting non-noble alloy FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3710 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental casting non-noble alloy

Zirlux by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental casting non-noble alloy.

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EC 610 — Cookson Precious Metals Ltd · Class IIa
TICONIUM — CMP INDUSTRIES LLC · Class II
NOBILIUM — CMP INDUSTRIES LLC · Class II
System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
Magnum Solare — Mesa Italia S.r.l. · Class IIa
NIRANIUM — CMP INDUSTRIES LLC · Class II
Matticraft 75+ — Cookson Precious Metals Ltd · Class IIa

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

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Manufacturer

Manufacturer: Henry Schein, Inc.

Sources (1)

FDA UDI 277aa2da-9d61-43ba-b34e-8f2b052515bb 34 fields · synced May 30, 2026