LYSTA LC CURING LIGHT, MODEL LC 2500C/BA

• K Number: K991138
• Device Name: LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
• Manufacturer: LYSTA A/S
• Date Cleared: 1999-04-23 ( 18 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: K992236

Intended Use

• Polymerization of light-cured dental materials
• Polymerization of restorative composite materials

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental curing light. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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.