BELLEGLASS HP ENAMEL 2

• K Number: K013007
• Device Name: BELLEGLASS HP ENAMEL 2
• Manufacturer: SYBRON DENTAL SPECIALTIES, INC.
• Date Cleared: 2001-10-01 ( 25 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

belleGlass HP Enamel 2 is a dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges.

Device Description

belleGlass HP Enamel 2 is dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. The belleGlass HP crown and bridge fabrication system is comprised of a!! the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental restorative material, "belleGlass HP Enamel 2." This document focuses on demonstrating substantial equivalence to a predicate device and securing market clearance from the FDA.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The information provided is for regulatory clearance based on substantial equivalence, not for a clinical or performance study demonstrating the device meets specific acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information from the provided text.

To answer your request, the document would need to include details of a study that measured specific performance metrics (e.g., wear resistance, bond strength, flexural strength) for belleGlass HP Enamel 2, compared these metrics against predefined acceptance criteria, and provided details on the study design, data, and analysis.

Regulation Number and Section

§ 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.