Tissium® Light

FDA UDI

Class II (US FDA UDI)

by Tissium SA

Identity

Trade Name: TISSIUM® LIGHT FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: The TISSIUM® LIGHT is a re-usable and non-sterile light source, indicated for the polymerization of TISSIUM® polymers. It is composed of two light pens, each with an internal rechargeable battery delivering a LED signal and one charging base with its power supply, including three adapter plugs (EU, UK and US). FDA UDI
Model / Reference: LTIOP0001 FDA UDI
Description: The TISSIUM® LIGHT is a re-usable and non-sterile light source, indicated for the polymerization of TISSIUM® polymers. It is composed of two light pens, each with an internal rechargeable battery delivering a LED signal and one charging base with its power supply, including three adapter plugs (EU, UK and US). FDA UDI

Identifiers

Catalog Number: LTIOP0001 FDA UDI
Primary DI / UDI-DI: 03760279380063 FDA UDI
FDA Product Code: SFD FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5270 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Dental/surgical polymerization lamp

Tissium® Light by Tissium SA — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Tissium SA

Sources (1)

FDA UDI c7ad68b3-ecc5-44ee-a604-3f9fc016c9b1 36 fields · synced May 30, 2026