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K Number
K172426
Device Name
Clear Blue Digi LED Curing Light
Manufacturer
Promident LLC
Date Cleared
2017-08-16

(6 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Clear Blue Digi LED curing light is a hand-held LED polymerization light intended to cure dental composites using visible light.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental device, the "Clear Blue Digi LED Curing Light." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific testing methodologies or results.

§ 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.