BLUEPHASE

• K Number: K033520
• Device Name: BLUEPHASE
• Manufacturer: IVOCLAR VIVADENT, INC.
• Date Cleared: 2003-12-05 ( 28 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Bluephase® is a hand held LED polymerization light intended to cure dental composites using visible light.

Device Description

Bluephase® is a hand held LED polymerization light

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is essentially an FDA clearance letter for a dental curing light, "Bluephase®", and while it confirms the device's classification and substantial equivalence, it does not include studies, acceptance criteria, sample sizes, or ground truth information relevant to AI/ML device performance. Therefore, I cannot generate the table or the detailed breakdown of a study's methodology as requested.

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.