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510(k) Data Aggregation
K Number
K024250Device Name
MATCH PRESS PRESSABLE CERAMICManufacturer
Date Cleared
2003-08-25
(245 days)
Product Code
Regulation Number
872.6660Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MATCH PRESS PRESSABLE CERAMIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.
Therefore, I cannot provide the requested information based on the given text.
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