AvaDent Denture Base Material

• K Number: K153590
• Device Name: AvaDent Denture Base Material
• Manufacturer: Global Dental Science
• Date Cleared: 2016-04-22 ( 128 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

AvaDent Denture Base Materials are intended for the fabrication of PMMA based acrylic dental prostheses including but not limited to partial and full dentures.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a dental device, "AvaDent Denture Base Material," not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as CFR parts, labeling, and adverse event reporting, but not technical performance data, acceptance criteria, or study results in the context of an AI/ML algorithm.

Without the actual study report for the device being evaluated, I cannot provide the requested information.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.