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510(k) Data Aggregation
K Number
K170894Device Name
Zirconia Dental CeramicsManufacturer
Date Cleared
2017-08-01
(127 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
Zirconia Dental Ceramics are intended for crowns, multiunit bridges. Application includes both anterior and posterior bridges.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Zirconia Dental Ceramics." It primarily addresses the substantial equivalence determination for the device and its indications for use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
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