MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC

• K Number: K983876
• Device Name: MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
• Manufacturer: MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND
• Date Cleared: 1998-12-16 ( 44 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental device (denture acrylic material) and does not contain information about acceptance criteria, device performance studies, or ground truth establishment. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical studies typically performed for AI/ML-based medical devices as per your request.

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.