K Number
K984483
Device Name
A-SOFT RELINER
Manufacturer
Date Cleared
1999-02-18

(64 days)

Product Code
Regulation Number
872.3760
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For relining and rebasing dentures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "A-Soft Reliner" device. It is a traditional medical device submission and therefore does not contain information about AI/ML acceptance criteria or studies. The letter indicates that the device is for "relining and rebasing dentures" and has been found substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information regarding AI/ML clinical studies, acceptance criteria, sample sizes, ground truth establishment, or expert details, as this information is not present in the provided text.

§ 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.