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K Number
K990736
Device Name
GC RELINE SOFT/EXTRA SOFT
Manufacturer
GC AMERICA, INC.
Date Cleared
1999-05-28

(84 days)

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

GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

Device Description

GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for "GC Reline Soft/Extra Soft". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, allowing it to be marketed. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

§ 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.