Tizian JMA Optic

FDA UDI

Class I (US FDA UDI)

by zebris MEDICAL GmbH

Identity

Trade Name: Tizian JMA Optic FDA UDI
Generic Name: Facebow FDA UDI
Device Name: Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and accessories FDA UDI
Model / Reference: 01570021 FDA UDI
Description: Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and accessories FDA UDI

Identifiers

Catalog Number: NA FDA UDI
Primary DI / UDI-DI: B915015700211 FDA UDI
FDA Product Code: NFS FDA UDI
GMDN Term: Facebow FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.2060 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Facebow

Tizian JMA Optic by zebris MEDICAL GmbH — 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: zebris MEDICAL GmbH

Sources (1)

FDA UDI 69aff691-5756-4ac9-9361-29ec4ebcfb0d 36 fields · synced May 30, 2026