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510(k) Data Aggregation
K Number
K993324Device Name
CARBOCEM ZINC POLYCARBOXYLATE CEMENTManufacturer
Date Cleared
1999-11-09
(36 days)
Product Code
Regulation Number
872.3275Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.
Device Description
Carbocem Zinc Polycarboxylate Cement
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a dental cement called Carbocem. It does not contain information about acceptance criteria or a study proving device performance in the context of the questions asked. The questions appear to be geared towards AI/ML device evaluations, which is not applicable to this traditional medical device clearance.
Therefore, I cannot provide the requested information based on the provided text.
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