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K Number
K974131
Device Name
ALERT
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
1997-12-17

(44 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

Tooth colored posterior restorative material

For usage in a similar situation that would be applicable to an amalgam restoration.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative material named "ALERT." As such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving those criteria.

A 510(k) clearance primarily establishes substantial equivalence to a predicate device, rather than requiring extensive clinical trials with detailed performance metrics and statistical analyses as might be found in a Premarket Approval (PMA) application or a more in-depth clinical study report.

Therefore, I cannot provide the requested information from this document. The document primarily confirms that the device can be marketed because it is substantially equivalent to existing devices and provides information on regulatory compliance.

§ 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.