Luxator 4 mm straight - Hu-Friedy - Delynov - Product for implantology, oral surgery, dental surgery, dentist, bone graft, maxillofacial surgery.
The Luxateur 4mm droit - 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.
What is the Hu-Friedy 4mm straight luxator?
The 4mm straight luxator is a manual oral surgery instrument manufactured by Hu-Friedy Mfg. Co., LLC. It consists of a straight working part with a width of 4mm, specifically sized to fit into the periodontal space. This device belongs to the category of consumables (CONSO) for the dental office. Its structure is optimized for the separation of ligament fibers surrounding the tooth. As a Class I instrument, it meets the basic regulatory requirements for non-invasive or invasive medical devices for temporary use. Its straight design allows direct access to surgical sites without major visual obstruction for the practitioner during the initial phases of extraction.
What are the clinical indications for this instrument?
This luxator is indicated for simple or complex tooth extraction procedures in oral surgery and implantology. Purchasing the 4mm straight luxator is particularly relevant for the initial luxation of the tooth or root before the application of a forceps. It is used to sever the periodontal ligament and widen the socket through axial pressure and slight rotation movements. Its use is common during the avulsion of single-rooted teeth or for the separation of roots after a crown section. The instrument facilitates the mobilization of the dental element while preserving the integrity of the alveolar bone plates, a crucial step for subsequent implant placement or maintenance of ridge volume.
What are the technical characteristics of the 4mm straight luxator?
The 4mm straight luxator from Hu-Friedy features a straight active tip with a precise width of 4mm. This dimension is calibrated to offer an ideal compromise between insertion fineness and mechanical resistance during luxation. Unlike standard elevators, the luxator blade is thinner to penetrate deeper into the periodontal space. The manufacturer Hu-Friedy Mfg. Co., LLC ensures rigorous manufacturing to maintain the sharpness necessary for severing ligament fibers. The instrument is designed to be sterilizable and reusable according to standard hygiene protocols in force in dental and maxillofacial surgery offices, in accordance with the instructions provided by the manufacturer.
What are the contraindications for the use of this device?
According to the information provided by Hu-Friedy, the use of this instrument is strictly reserved for qualified healthcare professionals. Contraindications include any clinical situation where the surrounding tissues or the patient's general condition do not allow for safe oral surgical intervention. It must not be used for functions other than dental luxation, such as excessive leverage on weakened bone structures that could lead to mandibular or maxillary fractures. The practitioner must refer to the specific indications and contraindications mentioned by Hu-Friedy 3232 N. Rockwell St. Chicago, Il 60618 USA. A rigorous preoperative assessment is necessary to rule out risks related to local bone pathologies.
What are the precautions for use and maintenance for this luxator?
As a non-resorbable and reusable device, the 4mm straight luxator requires strict maintenance. Although it is not a suture requiring resorption management, its longevity depends on compliance with cleaning, disinfection, and sterilization cycles. It is imperative to read the instructions carefully before use to understand the torsion and pressure limits allowed by the instrument. The manufacturer Hu-Friedy emphasizes that this device is reserved for healthcare professionals. A visual inspection before each intervention is recommended to check for the absence of micro-cracks or deformation of the 4mm working part, thus guaranteeing patient safety and the efficiency of the surgical gesture during luxation.
Who is the manufacturer and what standards are respected?
The 4mm straight luxator is manufactured by Hu-Friedy Mfg. Co., LLC, headquartered at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I according to current regulations. The manufacturer is internationally recognized for the quality of its surgical instrumentation. Compliance with manufacturing standards ensures that the instrument meets the safety and performance requirements for its intended use in a clinical environment. Healthcare professionals must ensure they follow the recommendations of the manufacturer Hu-Friedy regarding use and maintenance to guarantee the continued compliance of the product during its useful life. Traceability and manufacturing quality are pillars of the brand in supporting dental surgeons.
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Specifications
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