LogoFDA 510(k) Search
K Number
K101621
Device Name
LITE ART
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2010-08-23

(75 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

LITE ART is dental resin-based stain material intended to harmonize the color of polymer-based C&B composite resin restorations with surrounding natural dentition. Specific usage of this product is as follows: 1) To characterize and modify C&B composite resin or acrylic resin restorations and 2) To characterize and modify hard resin teeth and acrylic resin teeth.

Device Description

Not Found

AI/ML Overview

This letter is a 510(k) clearance for a dental resin material named "Lite Art." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific acceptance criteria.

§ 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.