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Dislocator 2mm Straight with SM Handle - Hu-Friedy - Delynov

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The Luxateur 2mm droit, manche SM - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.

  • Compliance: Medical device Class I.
  • Manufacturer: Hu-Friedy Mfg. Co., LLC.
  • Reserved for healthcare professionals. Read instructions carefully before use.

130.95 € 130.95 EUR 130.95 € Tax Included

130.95 € Tax Included

(0.00 € / Units)
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Instrument

What is the 2mm straight luxator, SM handle - Hu-Friedy?

The 2mm straight luxator with SM handle from the Hu-Friedy brand is a precision surgical instrument used in oral surgery. This device consists of a straight working part with a width of 2mm, designed to be inserted into the periodontal space. Manufactured by Hu-Friedy Mfg. Co., LLC, this instrument belongs to the category of manual luxation instruments. Its structure is optimized for handling by qualified healthcare professionals, offering a rigid interface for the transmission of forces during the initial stages of extraction. As a Class I device, it meets standard regulatory requirements for non-invasive or invasive instruments for temporary use.

What are the clinical indications for this Hu-Friedy instrument?

This instrument is specifically indicated for severing the periodontal ligament and widening the socket during tooth extractions. Its use occurs before the application of forceps to minimize root resistance. The 2mm straight tip allows access to interproximal areas and follows the root anatomy to break fibrous attachments. Hu-Friedy advocates this use to facilitate avulsion while preserving the integrity of the surrounding alveolar bone. It is exclusively reserved for healthcare professionals trained in oral surgery techniques, in accordance with the directives of the manufacturer located in Chicago, USA.

What are the technical characteristics of the 2mm straight luxator?

The luxator is distinguished by a straight active end with a precise width of 2mm, allowing fine insertion into the periodontium. The SM-type handle is designed to provide a grip adapted to the axial pressure and slight rotation movements necessary for luxation. This device is classified as Class I according to current regulations. The design by Hu-Friedy Mfg. Co., LLC guarantees an instrument whose geometry is studied to meet the mechanical constraints of oral surgery. The manufacturer, Hu-Friedy, ensures the traceability and compliance of this instrument intended for strict professional use in dental offices or hospital environments.

What are the contraindications for the use of this device?

According to information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for healthcare professionals. Contraindications include any clinical situation where standard extraction protocols cannot be followed or when surgical access does not allow for safe use of the instrument. It is imperative to read the instructions carefully before use to identify specific usage limits. Although the raw MDR text mentions the 'Indications and Contraindications' section, no specific medical contraindication related to a material or pathology is explicitly listed by the manufacturer in the provided source data.

What are the precautions for use and maintenance for this luxator?

As a non-resorbable Class I instrument, precautions are based on compliance with sterilization and maintenance protocols for steel surgical instruments. Before each procedure, the practitioner must check the integrity of the 2mm tip to ensure the absence of deformation or dullness that could compromise the effectiveness of the ligament sectioning. The manufacturer Hu-Friedy emphasizes the importance of following cleaning and sterilization instructions to maintain the instrument's performance. Since it is not a resorbable device, the question of hydrolysis does not apply, but durability depends on compliance with the thermal and chemical treatment cycles recommended by Hu-Friedy.

Who is the manufacturer and what standards are respected?

The official manufacturer of this luxator is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is listed under Class I, which implies compliance with safety and performance requirements for surgical instruments in this category. Hu-Friedy is a recognized manufacturer in the field of dental instrumentation, ensuring production compliant with professional healthcare standards. Users must systematically refer to the instructions for use and manufacturer warnings to guarantee use in accordance with the regulatory standards in force in the European Union and internationally.


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Specifications

Manufacturer Hu-Friedy
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