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PubMed · 11244528

Self-made tooth guard using Turbocast.

Y Talmon·P Gilbey
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Abstract

Tooth protection during suspension microlaryngeal surgery is a challenge when teeth are damaged or missing. We present an effective, disposable and cheap tooth guard for microlaryngeal surgical procedures using Turbocast. The tooth guard transits the laryngoscope's pressure directly to the hard palate leaving the teeth uninvolved and free of any pressure.

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Disposable EquipmentEquipment DesignHumansLaryngoscopyMouth ProtectorsTooth InjuriesJournal Article

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Y Talmon, P Gilbey. 2001. Self-made tooth guard using Turbocast.. https://doi.org/10.1258/0022215011907217

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PubMed2006

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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