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K Number
K993827
Device Name
UFI GEL HARD
Manufacturer
VOCO GMBH
Date Cleared
2000-01-20

(69 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

Ufi Gel hard is an acrylic resin used as a permanent hard relining for complete and partial dentures.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA to DenPlus, Incorporated regarding their device, Ufi Gel Hard. This letter serves as a Premarket Notification (510(k)) and indicates that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This document does NOT contain information about acceptance criteria, device performance, or any studies related to its performance. It specifically states that it is a substantial equivalence determination and does not delve into performance metrics or study methodologies. Therefore, I cannot answer your request based on 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.