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510(k) Data Aggregation
K Number
K023981Device Name
AHL GENERIC GLASS IONOMER LUTING CEMENTManufacturer
Date Cleared
2003-01-31
(60 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
For cementing crowns, bridges, onlays, inlays and orthodontic bands.
Caution; US Federal Law restricts this device to sale by or on the order of a dental professional.
Labels will bear this caution.
Device Description
AHL Generic Glass Ionomer Luting Cement
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA for a dental cement. It does not contain information about the acceptance criteria and study proving device performance as requested. Such details would typically be found in the manufacturer's 510(k) submission, specifically sections related to performance data.
Therefore, I cannot provide the requested information based on the given text.
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