GC E-LIGHT

• K Number: K012134
• Device Name: GC E-LIGHT
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2001-08-07 ( 29 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Source of illumination for curing visible light cured dental materials such as composites, bonding agents, and cements.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and the study description. The document is an FDA 510(k) clearance letter for a device called "GC E-Light," stating that the device is substantially equivalent to legally marketed predicate devices.

It does not include:

• Specific acceptance criteria metrics (e.g., accuracy, sensitivity, specificity, or quantitative performance thresholds).
• Any details about a study that proves the device meets these criteria.
• Information about sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, or results from standalone or MRMC studies.

The document only states the "Indications For Use" which is: "Source of illumination for curing visible light cured dental materials such as composites, bonding agents, and resin cements."

Therefore, I cannot generate the requested table and study description based on the provided text.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.