LogoFDA 510(k) Search
K Number
K033267
Device Name
EPRICORD
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2003-12-22

(74 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

Epricord is indicated for the following applications:

    1. Restorations using facing crowns, facing bridges, or jacket crowns.
    1. Repairs of the polymer crown and bridge material or porcelain of facing crowns and jacket crowns.
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental resin material named Epricord. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

  • Acceptance criteria for a study
  • Reported device performance values
  • Details of any specific study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details)

The content is purely an FDA regulatory clearance notice, not a study report or clinical trial summary.

§ 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.