FIT CHECKER II

• K Number: K032289
• Device Name: FIT CHECKER II
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2003-10-20 ( 88 days)
• Product Code: ELW
• Regulation Number: 872.3660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Silicone fit examining material used to detect high spots and pressure points of crowns, bridges, veneers, inlays and dentures.

Device Description

Not Found

AI/ML Overview

The provided text is a Letter of Substantial Equivalence from the FDA for a device named "FIT CHECKER II." This document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (such as MRMC or standalone studies).

It is a regulatory approval letter based on the device's substantial equivalence to a legally marketed predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).