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510(k) Data Aggregation
K Number
K172530Device Name
BEAUTIFIL Flow Plus XManufacturer
Date Cleared
2017-12-06
(107 days)
Product Code
Regulation Number
872.3690Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
• Anterior and posterior restorations • Repair of restorations and prostheses
Device Description
Not Found
AI/ML Overview
I am sorry but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA 510(k) clearance letter for a dental device, indicating it has been deemed substantially equivalent to a predicate device. It defines the device name, regulation number, and indications for use, but does not include any performance study details.
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