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510(k) Data Aggregation
K Number
K011223Manufacturer
Date Cleared
2001-09-20
(153 days)
Product Code
Regulation Number
872.3640Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002241Manufacturer
Date Cleared
2001-09-20
(423 days)
Product Code
Regulation Number
872.3640Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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