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K Number
K974413
Device Name
PERMAFLO
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1998-02-02

(70 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

PermaFlo can be used for:

    1. Anterior and posterior restorations, such as Class I, II, III, IV, and V.
    1. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
    1. Direct veneers and other restorative procedures
    1. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).
Device Description

PermaFlo Flowable Composite

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental product called Permaflo. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific acceptance criteria.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This means it has met the regulatory requirements for market clearance, not that its performance was evaluated against specific quantitative acceptance criteria in a clinical study.

Therefore, I cannot provide the requested information based on the content of these documents. The request asks for details about a study evaluating device performance, which is not present in this regulatory clearance letter.

§ 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.