QUADRANT CORE LC

• K Number: K984042
• Device Name: QUADRANT CORE LC
• Manufacturer: CAVEX HOLLAND B.V.
• Date Cleared: 1998-12-04 ( 21 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K041323

Intended Use

Quadrant Core LC is a light curing dental composite filling material used in the adhesive restorative technique.

Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.

Quadrant Core LC is especially designed for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

Device Description

Quadrant Core LC is a light curing dental composite filling material.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental composite filling material, "Quadrant Core LC," indicating that the device has been found substantially equivalent to a legally marketed predicate device. It does not contain any details about studies or data that would address your specific questions regarding acceptance criteria and device performance evaluation.

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.