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510(k) Data Aggregation
K Number
K143486Device Name
Ufi Gel hard CManufacturer
Date Cleared
2015-01-07
(30 days)
Product Code
Regulation Number
872.3760Type
SpecialPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
- hard permanent total or partial relinings for restoring partial and complete dentures - lengthening denture margins
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental relining material (Ufi Gel hard C). It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided input.
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