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510(k) Data Aggregation
K Number
K152471Device Name
CAPO BULK FILLManufacturer
Date Cleared
2016-08-04
(339 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
- Fillings with layer thicknesses up to 4 mm in Black's class I and II cavities
- Cavity lining - as a first (bottom) layer in Black's class I and II cavities
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a dental material (Capo Bulk Fill), not an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance. The document describes the regulatory classification and indications for use of a tooth shade resin material.
As such, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from this text.
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