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510(k) Data Aggregation
Device Name
SEALAPEX 4Manufacturer
Date Cleared
2001-06-20
(83 days)
Product Code
Regulation Number
872.3820Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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