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K Number
K060893
Device Name
MODIFICATION TO REBILDA DC
Manufacturer
VOCO GMBH
Date Cleared
2006-05-25

(52 days)

Product Code
EBF
Regulation Number
872.3690
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
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.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.