SmartLite® Pro

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name: SmartLite® Pro FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: SmartLite® Pro EndoActivator™ Sleeves FDA UDI
Model / Reference: 644434 FDA UDI
Description: SmartLite® Pro EndoActivator™ Sleeves FDA UDI

Identifiers

Catalog Number: 644434 FDA UDI
Primary DI / UDI-DI: D0026444341 FDA UDI
FDA Product Code: PEM FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental/surgical polymerization lamp

SmartLite® Pro by Dentsply International — 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: Dentsply International

Sources (1)

FDA UDI eb2e606e-822a-4b76-9117-49de6f79dff2 37 fields · synced May 30, 2026