FORMCORE DC, MODEL 28-700100

• K Number: K061664
• Device Name: FORMCORE DC, MODEL 28-700100
• Manufacturer: J. MORITA USA, INC.
• Date Cleared: 2006-09-08 ( 86 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

FormCore DC is a dual cure dental material intended to be used for core build up.

Device Description

FormCore DC is a dual cure dental material.

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "FormCore DC" device. It is a clearance letter, not a study report or a summary of acceptance criteria and performance data. Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, ground truth types, and training set information, is not available in the provided text.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their K061664 submission, which would have included data to demonstrate substantial equivalence, but that data is not part of this letter itself.

Regulation Number and Section

§ 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.