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510(k) Data Aggregation
K Number
K024287Device Name
FIXOBRIDGE 3-CEMENTManufacturer
Date Cleared
2003-03-21
(88 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
A temporary cement for fixing dental bridges, temporary crowns or bridges, and all metal, porcelain and acrylic crowns.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) premarket notification letter from the FDA regarding the "Fixobridge 3-Cement" device. It primarily discusses the substantial equivalence of this dental cement to legally marketed predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance studies with acceptance criteria.
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