LogoFDA 510(k) Search
K Number
K984044
Device Name
QUADRANT POSTERIOR DENSE
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
1998-12-16

(33 days)

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

Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound dental tissue. Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.

Device Description

light curing dental composite filling material

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental filling material. It does not contain any information about acceptance criteria, device performance, a study, or any of the other details requested in your prompt regarding artificial intelligence or medical imaging devices. Therefore, I cannot fulfill your request based on the given input.

§ 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.