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510(k) Data Aggregation
K Number
K233518Device Name
BASE290 LED Curing LightManufacturer
Date Cleared
2023-11-02
(1 days)
Product Code
Regulation Number
872.6070Type
TraditionalPanel
Dental Devices (DE)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
BASE290 LED Curing Light
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.
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