SmartLite Focus

FDA UDI

Class II (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name: SmartLite Focus FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately. FDA UDI
Model / Reference: 64450050 FDA UDI
Description: SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately. FDA UDI

Identifiers

Catalog Number: 64450050 FDA UDI
Primary DI / UDI-DI: D010644500501 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 7.5 Centimeter FDA UDI

Category: Dental/surgical polymerization lamp

SmartLite Focus by Dentsply De Trey GmbH — 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 De Trey GmbH

Sources (1)

FDA UDI 2fd3435e-9932-4013-bf77-28adb625f86d 36 fields · synced Jun 8, 2026