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510(k) Data Aggregation
K Number
K993475Device Name
AUROFLUID M, ALLOY NO. 5315Manufacturer
Date Cleared
1999-12-09
(56 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Fabrication of Dental Crowns, Bridges, Inlays and Cast Partial-denture Frames.
Device Description
Not Found
AI/ML Overview
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental material called "Aurofluid M." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on performance studies or acceptance criteria for a new device's performance.
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