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K Number
K160596
Device Name
BEAUTIFIL II LS
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2016-07-27

(147 days)

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

BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material indicated for anterior and posterior restorations including occlusal surfaces.
(Indications)
· Anterior and posterior restorations
· Repair of restorations and prostheses

Device Description

BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or statistical analyses typically found in a scientific study or clinical trial report. Therefore, I cannot extract the requested information from this document.

§ 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.