Lumindex 3 LED Transilluminator

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.…

Registry build 21.09.26

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,

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HJN
Manufacturer City Province Registered as Device types
Vincent Medical(Dongguan)Technology Company Limited Dongguan Guangdong Contract manufacturer 2
Zumax Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 19

Record

Regulatory record for Lumindex 3 LED Transilluminator
Listed by Practicon, Inc., United States
FDA product code HJN
Device type Transilluminator, Battery-Powered
Device class Class 1
Regulation 21 CFR 886.1945
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-07-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Lumindex 3 LED Transilluminator
Catalogue number Size Status
7118835 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 9
NeoGlo® Neotech Products, LLC 9
zumax Zumax Medical Co., Ltd. 4
Bernell Bernell 3
Lumindex Dentmate Technology Co., Ltd. 3
NeoGlo Disposable Neotech Products, LLC 2
Amico Diagnostic Illuminator Amico Diagnostic Incorporated 2
Venoscope Venoscope, LLC 2
VF1000LED Vein locator Fabinject Industria E Comercio Importacao E Exportacao Ltda 1
EZ-TRI-3600 U.S. Ophthalmic, L.L.C. 1
Astodia Stihler Electronic Gmbh 1
ESU Transilluminator ESU Limited Liability Partnership 1

Showing 12 of 15. All products under Transilluminator, Battery-Powered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer