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510(k) Data Aggregation
K Number
K970256Device Name
INTRAORAL MANDIBULAR DISTRACTION DEVICEManufacturer
Date Cleared
1997-03-11
(47 days)
Product Code
Regulation Number
872.4760Type
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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