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K Number
K981264
Device Name
ARISTON PHC
Manufacturer
IVOCLAR USA, INC.
Date Cleared
1998-07-02

(86 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

Intended Use: Ariston pHc filling material is intended to be used for Intended USE. Allscon pho firming indeciduous and permanent teeth with Crass I and if reparations and for an amalgam substitute.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental filling material called "Ariston pHc", indicating it has been found substantially equivalent to a predicate device.

The letter mentions the device's intended use and regulatory classification, but it does not detail specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a performance study.

§ 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.