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K Number
K030072
Device Name
EVERSTICK PERIO
Manufacturer
STICK TECH LTD.
Date Cleared
2003-04-10

(92 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K011788
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For periodontal splinting

Device Description

everStick™ PERIO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ PERIO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a product called "everStick™ PERIO", detailing its description, intended use, and substantial equivalence to a predicate device, but it does not include performance data, study designs, or ground truth information.

§ 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.