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K Number
K162654
Device Name
mollosil plus
Manufacturer
DETAX GmbH & Co.KG
Date Cleared
2017-03-13

(171 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

Used for fabricating long-term soft denture relinings by direct or indirect application.

Device Description

Not Found

AI/ML Overview

This FDA document is a clearance letter for a dental device, "Mollosil Plus," classifying it as substantially equivalent to existing predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.

§ 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.