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510(k) Data Aggregation
K Number
K133211Device Name
ZIRTOUGHManufacturer
Date Cleared
2014-03-20
(153 days)
Product Code
Regulation Number
872.6660Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
ZirTough is used for fabricating the all-ceramic dental frameworks or FCZ (=Full Contour Zirconia) crowns and bridges.
Device Description
Not Found
AI/ML Overview
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) clearance letter from the FDA for a dental product called ZirTough. The letter confirms that ZirTough is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or ground truth methods.
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