ACRON MC MODIFICATION

• K Number: K991774
• Device Name: ACRON MC MODIFICATION
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 1999-07-09 ( 45 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Acron MC is a powder/liquid microwave curing denture base resin.

Device Description

Not Found

AI/ML Overview

This document (K991774) is a 510(k) premarket notification letter from the FDA regarding the Acron™ MC dental device. It does not contain any information about acceptance criteria for a device, a study proving the device meets acceptance criteria, or any of the detailed information requested in your prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details).

This letter primarily states that the FDA has reviewed the submission and determined that the Acron™ MC modification is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also outlines general regulatory information for the manufacturer.

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.