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K Number
K143486
Device Name
Ufi Gel hard C
Manufacturer
VOCO GMBH
Date Cleared
2015-01-07

(30 days)

Product Code
EBI
Regulation Number
872.3760
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • hard permanent total or partial relinings for restoring partial and complete dentures - lengthening denture margins
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental relining material (Ufi Gel hard C). It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided input.

§ 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.