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510(k) Data Aggregation
K Number
K960596Device Name
ORION-I CORE BUILD-UP MATERIAL CHEMICAL CUREManufacturer
Date Cleared
1996-04-26
(74 days)
Product Code
Regulation Number
872.3690Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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