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510(k) Data Aggregation
K Number
K991844Device Name
PRO-GLASSManufacturer
Date Cleared
1999-07-21
(54 days)
Regulation Number
872.6660Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The indicated usage for this product is as a machinable ceramic for use in the construction of ceramic Fixed Restorations.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter for a dental device called "Pro-Glass." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
The document does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided input.
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