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Lumindex 3 LED Transilluminator

FDA UDI

Class I (US FDA UDI)

by Practicon, Inc.

Identity

Trade Name
Lumindex 3 LED Transilluminator FDA UDI
Generic Name
ENT transilluminator FDA UDI
Device Name
With its brilliant white LED, the Lumindex 3 LED Transilluminator is ideal for diagnosing tooth fractures, detecting carious lesions and calculus, and locating hard-to-see root canals. Simply press the single ON/OFF button once for a high-intensity 30,000 lux beam, or press it again for lower-intensity 15,000 lux output. A third press turns the unit off. Lumindex 3 features an automatic power compensation circuit for consistent, constant output during the life of the batteries, as well as a low battery LED indicator. And Lumindex 3 turns itself off automatically after five minutes to conserve batteries. Handpiece can be cleaned easily with disinfectant wipes. Light guide is autoclavable to 273°F. Specifications: Light source: High-power LED. Color temperature: 6,500K. Radiant intensity at 5mm: Low Mode: 15,000 lux. High Mode: 30,000 lux. Batteries: (2) 1.5V AAA alkaline. Battery life: 3 hours (high power mode). Dimensions: 187mm (7-3/8") L x 16mm (5/8") max. diameter. Package includes Lumindex 3 handpiece, standard 3mm light guide, two AAA alkaline batteries, FDA UDI
Model / Reference
7118835 FDA UDI
Description
With its brilliant white LED, the Lumindex 3 LED Transilluminator is ideal for diagnosing tooth fractures, detecting carious lesions and calculus, and locating hard-to-see root canals. Simply press the single ON/OFF button once for a high-intensity 30,000 lux beam, or press it again for lower-intensity 15,000 lux output. A third press turns the unit off. Lumindex 3 features an automatic power compensation circuit for consistent, constant output during the life of the batteries, as well as a low battery LED indicator. And Lumindex 3 turns itself off automatically after five minutes to conserve batteries. Handpiece can be cleaned easily with disinfectant wipes. Light guide is autoclavable to 273°F. Specifications: Light source: High-power LED. Color temperature: 6,500K. Radiant intensity at 5mm: Low Mode: 15,000 lux. High Mode: 30,000 lux. Batteries: (2) 1.5V AAA alkaline. Battery life: 3 hours (high power mode). Dimensions: 187mm (7-3/8") L x 16mm (5/8") max. diameter. Package includes Lumindex 3 handpiece, standard 3mm light guide, two AAA alkaline batteries, FDA UDI

Identifiers

Catalog Number
71-18835 FDA UDI
Primary DI / UDI-DI
00723896009048 FDA UDI
FDA Product Code
HJN FDA UDI
GMDN Term
ENT transilluminator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1945 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ENT transilluminator

Lumindex 3 LED Transilluminator by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT transilluminator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Practicon, Inc.

Sources (1)

  • FDA UDI b47ecec5-1dd5-4402-ba4c-a74994cd3d73 34 fields · synced Jun 8, 2026