Search Results
Found 1 results
510(k) Data Aggregation
K Number
K051203Device Name
BLUELEXManufacturer
Date Cleared
2005-05-25
(14 days)
Product Code
Regulation Number
872.6070Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) premarket notification approval letter for a dental device, the BlueLEX LD-105 Ultraviolet Activator for Polymerization. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested information based on the input.
Ask a Question
Ask a specific question about this device
Page 1 of 1