SPRING POWERLITE 2000

• K Number: K992728
• Device Name: SPRING POWERLITE 2000
• Manufacturer: SPRING HEALTH PRODUCTS, INC.
• Date Cleared: 1999-09-29 ( 47 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

High Intensity light for polymerization of dental materials and tooth whitening.

Device Description

Not Found

AI/ML Overview

I apologize, but this document is a 510(k) clearance letter from the FDA for a device called "Spring PowerLite 2000." It primarily states that the device has been found substantially equivalent to existing devices and can be marketed.

However, the provided text does not contain any information regarding the acceptance criteria, the study details (like sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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.