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K Number
K992176
Device Name
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
Manufacturer
ST. GEORGE TECHNOLOGY, INC.
Date Cleared
2000-02-10

(227 days)

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

Excel Ultra-Hi Formula Heat-Cured Denture Base material is indicated for use in the fabrication, repairing, relining and/or rebasing of full or partial removable prosthetic devices.

Device Description

Excel Ultra-Hi Formula Heat-Cured Denture Base

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding the marketing clearance of a denture base material, not a study evaluating a medical device's performance against acceptance criteria. Therefore, I cannot extract details about acceptance criteria, device performance, study design, or expert involvement as these are not present in the 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.