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K Number
K982191
Device Name
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-09-14

(84 days)

Product Code
EBF,DAT
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

Device Description

Chemical Cure Composite with Enamel Bond

AI/ML Overview

I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental composite material. It confirms that the device is substantially equivalent to previously marketed devices. However, it does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or effects of AI assistance. The document focuses on regulatory approval rather than detailed study results.

§ 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.