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K Number
K993488
Device Name
LIGHT-CORE
Manufacturer
BISCO, INC.
Date Cleared
1999-11-10

(26 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K882006
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Core build-up composite for use with a 4th or 5th generation adhesive system.

Device Description

Light-Core is a translucent, fiber-reinforced, light-cured core build-up composite for use with a 4th or 5th generation adhesive system.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental core build-up composite called "Light-Core™", outlining its characteristics and comparing it to a predicate device. It includes the intended use, chemical composition, physical/mechanical properties, biocompatibility, depth of cure, physical description, and handling time. However, it does not specify any quantitative acceptance criteria or a study's results against such criteria.

Therefore, I cannot provide the requested information.

§ 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.