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K Number
K991687
Device Name
MODIFICATION TO LINER II: SOFT RELINE LIQUID
Manufacturer
BOSWORTH CO.
Date Cleared
1999-10-07

(143 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

Soft Reline is a visible light cure soft reline material for removable dentures. It is intended for short-term use of at least 30 days.

Device Description

Soft Reline is a visible light cure soft reline material for removable dentures.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device called "Liner II: Soft Reline Liquid." This document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria or a study demonstrating achievement of those 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.