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K Number
K103391
Device Name
IVOBASE HYBRID, IVOBASE HIGH IMPACT
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-02-17

(90 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

IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental device (IvoBase Hybrid and IvoBase High Impact). It states that the device is substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the requested table and provide the study details based on the provided text. The FDA clearance letter confirms regulatory approval based on substantial equivalence, but it does not include the underlying technical study data or acceptance criteria.

§ 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.