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K Number
K973924
Device Name
FRIOS BONESHIELD
Manufacturer
FRIATEC AG
Date Cleared
1998-05-07

(204 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Friatec Bone Shield is indicated for use for insuring three dimensional alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

The document is a 510(k) clearance letter from the FDA to FRIATEC AG for their device called "Frios Boneshield." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. The "Indications For Use" provided describe the purpose of the device (insuring three-dimensional alveolar bone defects and facilitating augmentation), but not its performance metrics or acceptance criteria from a study.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.