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K Number
K233518
Device Name
BASE290 LED Curing Light
Manufacturer
Handpiece Headquarters
Date Cleared
2023-11-02

(1 days)

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

This "BASE290 LED Curing Light" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 380-500 nm by dental professionals.

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 does not contain information about the acceptance criteria, study details, or performance metrics of a device, nor does it discuss ground truth, human experts, or AI.

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

§ 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.