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K Number
K092912
Device Name
STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2009-12-16

(85 days)

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

StarFill 2B HV and LV are dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate.

Device Description

dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative material, Starfill 2B HV and LV. It does not contain information about acceptance criteria or a study proving that a device meets such criteria because it pertains to a material, not an AI/ML powered device. Therefore, I cannot extract the requested information from this 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.