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510(k) Data Aggregation
K Number
K030807Device Name
CARIES INDICATORManufacturer
Date Cleared
2003-06-09
(88 days)
Product Code
Regulation Number
872.1740Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.
Device Description
Not Found
AI/ML Overview
This FDA letter confirms substantial equivalence for a Caries Indicator device (K030807), but it does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include performance data or details of clinical studies.
Therefore, I cannot provide the requested information based on the provided text.
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