MI FLOW (GCUC-450)

• K Number: K090747
• Device Name: MI FLOW (GCUC-450)
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2009-06-10 ( 82 days)
• Product Code: EBF , EBC
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Restoration of Class I, II, III, IV, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting of mobile teeth Additions to composite restorations

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental material (MI Flow), not a study report for an AI-powered medical device. Therefore, it does not contain the information required to answer the prompt.

Specifically, the document does not include:

• Acceptance criteria table and reported device performance for an AI/CADe device.
• Details about a study demonstrating the device meets acceptance criteria (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance).
• Information about training sets.

This document is a regulatory approval for a dental restorative material, confirming its substantial equivalence to previously marketed devices based on its physical and chemical properties and intended use, not its diagnostic performance based on image analysis.

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.