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K Number
K982537
Device Name
TOKUYAMA SOFRELINER
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1998-08-24

(34 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K990666,K021382,K973950,K791696
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a denture reliner

Device Description

The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or any study that proves a device meets such criteria. The document is a 510(k) summary for a denture relining resin material (Tokuyama SOFRELINING) and a letter from the FDA determining substantial equivalence to predicate devices. It discusses the device's classification, indications for use, and regulatory compliance but does not detail performance acceptance criteria or specific studies beyond referencing the 510(k) notification.

§ 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.