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510(k) Data Aggregation
K Number
K051866Device Name
PREMIER TEMPORARY CEMENTManufacturer
Date Cleared
2005-09-06
(57 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
Dental Devices (DE)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
PREMIER TEMPORARY CEMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.
Device Description
Not Found
AI/ML Overview
This looks like a 510(k) clearance letter for a dental cement, not an AI/ML device. Therefore, the requested information about acceptance criteria, clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable.
The document discusses substantial equivalence to a predicate device based on regulatory requirements for dental cements, not performance metrics of an AI algorithm.
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