NATURE-CRYL HI PLUS

• K Number: K051358
• Device Name: NATURE-CRYL HI PLUS
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2005-07-07 ( 44 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For use in the fabrication of full and partial dentures using conventional heat cured dough pack and or injection processing technique.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental resin, Nature-Cryl™ Hi Plus, used for fabricating dentures. It is not a study that proves a device meets acceptance criteria.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in this type of regulatory correspondence.

The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. It does not contain the detailed performance study information you are asking for.

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.