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510(k) Data Aggregation
K Number
K000588Device Name
DIMENSION GARANT L, DIMENSION GARANT L QUICKManufacturer
Date Cleared
2000-03-30
(37 days)
Product Code
Regulation Number
872.3660Type
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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