LogoFDA 510(k) Search
K Number
K984365
Device Name
GC UNIFAST TRAD
Manufacturer
GC AMERICA, INC.
Date Cleared
1999-02-25

(80 days)

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

GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.

Device Description

GC Unifast Trad is an acrylic resin.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "GC Unifast Trad". It does not contain information about acceptance criteria or a study proving device performance as would be found in a clinical study report or a more detailed submission summary.

Therefore, I cannot extract the requested information using only the provided text. The document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results.

§ 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.