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K Number
K022975
Device Name
ETCHING 15
Manufacturer
AB ARDENT
Date Cleared
2002-11-22

(77 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

E.TCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to AB Ardent for their device ETCHING 15. It details the regulatory approval process and general controls applicable to the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide the requested table or information based on the provided text.

§ 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.