BEAUTIFIL Flow Plus X

• K Number: K172530
• Device Name: BEAUTIFIL Flow Plus X
• Manufacturer: Shofu Dental Corporation
• Date Cleared: 2017-12-06 ( 107 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

• Anterior and posterior restorations • Repair of restorations and prostheses

Device Description

Not Found

AI/ML Overview

I am sorry but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA 510(k) clearance letter for a dental device, indicating it has been deemed substantially equivalent to a predicate device. It defines the device name, regulation number, and indications for use, but does not include any performance study details.

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.