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K Number
K030915
Device Name
GRANDIO
Manufacturer
VOCO GMBH
Date Cleared
2003-05-30

(67 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fillings of class I to V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors Correction of shape and shade for better aesthetic appearance Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core-build-up under crowns Composite inlays

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary from the FDA for a dental resin material named "Grandio." It does not contain information about the acceptance criteria and study details for an AI-powered device. Therefore, I cannot fulfill your request for that specific information based on the given text.

§ 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.