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510(k) Data Aggregation
K Number
K973201Device Name
PROVI CEMENTManufacturer
Date Cleared
1998-06-05
(283 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
TEMPORARY CEMENT FOR DENTAL USE ONLY.
Device Description
Not Found
AI/ML Overview
Given the provided text, none of the requested information regarding acceptance criteria or a study proving a device meets those criteria is present. The document is an FDA 510(k) clearance letter for a device called "Provi Cement," indicating that it has been found substantially equivalent to a legally marketed predicate device. This letter does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table or answer questions 2 through 9 based on the given input.
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