PERMAQUICK SE BONDING SYSTEM

• K Number: K032626
• Device Name: PERMAQUICK SE BONDING SYSTEM
• Manufacturer: ULTRADENT PRODUCTS, INC.
• Date Cleared: 2003-12-03 ( 99 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: K063558

Intended Use

Us : for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:

• 1. Dentin and Enamel using composite or amalgam
• 2. Porcelain
• 3. Metal
• 4. Composite repair

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification letter for the PermaQuick SF Bonding System. The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or study results that prove the device meets acceptance criteria.

The provided text is a regulatory clearance letter and an "Indications For Use" statement. It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for any studies.
3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Information about training set size or how its ground truth was established.

Therefore, I cannot fulfill your request for this information based on the provided input.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.