ULTRA-LITE 200E LIGHT CURE UNIT

• K Number: K023545
• Device Name: ULTRA-LITE 200E LIGHT CURE UNIT
• Manufacturer: ROLENCE ENT. INC.
• Date Cleared: 2002-12-30 ( 69 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510(k)) letter for a dental device, specifically a light cure unit. Based on the provided text, the document focuses on the regulatory aspects of the device's clearance and does NOT contain information about performance acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical studies with specific performance metrics as might be seen for novel or higher-risk devices.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification and validation report, or a clinical study report.

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.