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Zirlux

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Zirlux FDA UDI
Generic Name
Dental prosthesis bite verification device FDA UDI
Device Name
Zirlux Bite Ver Cyl Eng FDA UDI
Model / Reference
9010924 FDA UDI
Description
Zirlux Bite Ver Cyl Eng FDA UDI

Identifiers

Catalog Number
9010924 FDA UDI
Primary DI / UDI-DI
H65890109240 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental prosthesis bite verification device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental prosthesis bite verification device

A dental prosthesis bite verification device that connects the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production.

Similar devices

Also classified as Dental prosthesis bite verification device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 70686e71-5b50-4cc6-94a2-69bfd28fd2b9 34 fields · synced Jul 24, 2026