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K Number
K013375
Device Name
BELLEGLASS HP OPAQUE 2
Manufacturer
KERR DENTAL MATERIALS CENTER
Date Cleared
2001-10-29

(18 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

BelleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.

Device Description

belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations. belleGlass HP Opaque 2 is also used with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

AI/ML Overview

This document is a 510(k) Summary for the BelleGlass HP Opaque 2, a dental material. It does not contain information about acceptance criteria or a study proving device performance as it is a premarket notification for a dental material, not an AI/ML powered device. Therefore, I cannot provide the requested information based on the provided 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.