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K Number
K012528
Device Name
ICE
Manufacturer
SOUTHERN DENTAL INDUSTRIES, LTD.
Date Cleared
2001-10-22

(77 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

Microfil hybrid restorative for all cavity classes, veneers and diastema closures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA document (K012528) does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) performance.

This document is a 510(k) clearance letter for a dental composite product called "ICE." It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance information.

Therefore, I cannot provide the requested table and study details as they are not present in the input 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.