2mm curved luxating elevator, Black Line - Hu-Friedy - Delynov

What is the 2mm curved Luxating Instrument, Black Line - Hu-Friedy?

The 2mm curved luxating instrument, Black Line, manufactured by Hu-Friedy, is a precision manual instrument intended for oral surgery. This device is distinguished by its Black Line finish, a specific range from the manufacturer Hu-Friedy Mfg. Co., LLC, designed to meet the requirements of practitioners. Its structure includes a 2mm active tip, whose curvature is specifically designed to insert into the ligament space. Unlike standard elevators, this dental luxating instrument has a thin blade allowing deep penetration along the root. This instrument is a Class I medical device, guaranteeing its compliance with manufacturing standards for non-invasive or reusable surgical tools after sterilization.

What are the clinical indications for this curved dental luxating instrument?

This curved dental luxating instrument is primarily indicated during the initial phases of simple or complex exodontia. In dental and implant surgery, it is used to cut the ligament fibers surrounding the tooth. Its clinical use allows for the creation of sufficient space for the subsequent insertion of forceps or wider elevators. The 2mm tip is particularly suitable for thin roots or areas of difficult access where a straight instrument would not allow an optimal angle of attack. It is used by dental surgeons to minimize the pressure exerted on the alveolar bone, thus preserving the bone architecture before potential implant placement. Its use is strictly reserved for qualified healthcare professionals.

What are the technical characteristics of this Hu-Friedy instrument?

The Hu-Friedy Black Line 2mm curved luxating instrument presents rigorous technical specifications. Its active tip measures 2mm in width, a critical dimension for precision in confined spaces. The curvature of the blade is designed to follow the radicular anatomy, thus facilitating the luxation movement. Hu-Friedy's Black Line technology offers a surface finish that reduces reflections under operatory lighting, thereby improving direct visibility for the surgeon. As a Class I product, it meets the quality requirements of Hu-Friedy Mfg. Co., LLC. The ergonomics of the handle are designed to ensure controlled force transmission, avoiding accidental slips during the sectioning of the periodontal ligament.

What are the contraindications for the use of this device?

The contraindications for the use of this dental luxating instrument primarily concern clinical situations where the integrity of the instrument or the safety of the patient cannot be guaranteed. Although the raw MDR text does not list specific medical contraindications related to materials, the use of this instrument is prohibited for excessive leverage functions that would exceed its structural strength, as it is designed for luxation and not for forceful elevation. It must not be used by persons not trained in oral surgery techniques. The manufacturer Hu-Friedy emphasizes the importance of reading the instructions carefully before use to identify any specific warnings related to the handling of Class I surgical instrumentation.

What are the maintenance and durability precautions?

As a non-resorbable and reusable instrument, the Black Line 2mm curved luxating instrument requires a strict sterilization protocol between each patient. Precautions for use include a systematic visual inspection of the 2mm tip to detect any signs of wear, bending, or corrosion. The Hu-Friedy Black Line finish must be preserved by using appropriate cleaning solutions, in accordance with the recommendations of the manufacturer Hu-Friedy Mfg. Co., LLC. Inadequate maintenance could alter the cutting properties of the blade and compromise the effectiveness of the dental luxation. It is imperative to follow standard decontamination and autoclave cycles to maintain the microbiological safety of the Class I device.

Who is the manufacturer and what standards are respected?

The official manufacturer of this instrument is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This luxating instrument is classified as a Class I medical device according to current regulations. Hu-Friedy is a recognized manufacturer in the dental sector for the precision of its surgical instruments. Compliance with manufacturing standards ensures that the curved dental luxating instrument meets safety and performance requirements for professional use in dental offices or hospital settings. Practitioners must refer to the instructions for use provided by Hu-Friedy to ensure implementation in accordance with public health directives and established clinical protocols.

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