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510(k) Data Aggregation
K Number
K060893Device Name
MODIFICATION TO REBILDA DCManufacturer
Date Cleared
2006-05-25
(52 days)
Product Code
Regulation Number
872.3690Type
SpecialPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODIFICATION TO REBILDA DC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Rebilda DC is intended for core build-up of vital and non-vital teeth
Device Description
Not Found
AI/ML Overview
I am sorry, but this document is a 510(k) clearance letter for a dental device (Rebilda DC) and does not contain the information you requested regarding acceptance criteria, study details, ground truth establishment, or sample sizes for an AI/ML device. This document is a regulatory approval, not a technical performance study report.
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