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510(k) Data Aggregation
K Number
K982606Device Name
AUROFLUID CPFManufacturer
Date Cleared
1998-10-15
(80 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For Use in the Fabrication of Dental Crowns, Bridges, Inlays and Onlays.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product called "Aurofluid CPF". This document primarily focuses on regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given text.
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