PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL

• K Number: K022675
• Device Name: PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
• Manufacturer: PRIME DENTAL MANUFACTURING, INC.
• Date Cleared: 2002-11-07 ( 87 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.

Device Description

Prime-Dent® Automix Dual Cure Core Build-Up Material

AI/ML Overview

This is an FDA Premarket Notification (510(k)) K022675 for a dental material (Prime-Dent® Automix Dual Cure Core Build-Up Material), not a medical device that would typically undergo studies to demonstrate performance against computational acceptance criteria. The document is primarily concerned with establishing substantial equivalence to a predicate device based on material properties and intended use.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this type of submission.

The FDA's review for this device focused on its intended use as a "dental core build-up material either with adhesives or with pins or posts" and its classification as a "Tooth Shade Resin Material" under 21 CFR 872.3690. Substantial equivalence was determined based on comparisons to legally marketed predicate devices, not through a performance study against specific computational metrics.

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.