Sterilizable Marker IMS [IMS-1235] - Hu-Friedy - Delynov

What is the Black Line Slim 3mm long curved Luxator?

The 3mm curved slim luxator, belonging to the Black Line range from Hu-Friedy, is a manual instrument designed for oral surgery. Its structure is distinguished by a fine working end and a specific curvature allowing it to reach difficult-to-access areas. This medical device is manufactured by Hu-Friedy Mfg. Co., LLC, a recognized manufacturer in the field of surgical instrumentation. Unlike standard elevators, this slim luxator is optimized for deep insertion along the dental root to break ligament fibers with high precision.

What are the clinical indications for this instrument?

This slim luxator is primarily indicated during the initial phases of dental extraction, notably for the luxation of roots and multi-rooted teeth. In implant and oral surgery, it is used to minimize alveolar bone compression, thus promoting the preservation of the vestibular bone plate. Its curved profile is particularly suitable for posterior sectors or areas where the angulation of surgical access requires an ergonomic instrument. It allows for the initiation of tooth mobility in a controlled manner before the use of forceps.

What are the technical characteristics of the Hu-Friedy luxator?

The curved slim luxator features a 3mm blade width, offering an ideal compromise between fineness and mechanical resistance. Hu-Friedy's Black Line technology incorporates a specific coating that improves visual contrast at the surgical site and reduces reflections under scialytic lighting. The long and curved design facilitates leverage and access in deep sockets. This instrument belongs to Class I according to medical device regulations, guaranteeing its compliance with manufacturing standards for reusable surgical instruments.

What are the contraindications for the use of this device?

The use of this luxator is contraindicated in patients with pathologies or clinical conditions that do not allow for standard oral surgery intervention. Although the raw MDR text does not list specific contraindications related to materials, it is imperative to refer to the instructions for use provided by Hu-Friedy. The instrument must not be used as a lever with excessive force (such as a Winter elevator) at the risk of weakening the fine 3mm tip or causing unwanted alveolar fractures.

What are the maintenance and use precautions?

As a non-resorbable and reusable instrument, this luxator requires a rigorous sterilization protocol between each patient. It is exclusively reserved for qualified healthcare professionals. Before each use, the practitioner must inspect the integrity of the 3mm tip and the condition of the Black Line finish. It is recommended to follow the cleaning and disinfection instructions from the manufacturer Hu-Friedy to maintain the cutting properties and longevity of the surgical steel. Careful handling prevents premature dulling of the sharp edges.

Who is the manufacturer and what standards are met?

The device is manufactured by Hu-Friedy Mfg. Co., LLC, headquartered in Chicago, USA. This product is classified as a Class I medical device. It meets the strict regulatory requirements for surgical instruments intended for dental and oral practice. Professionals must imperatively read the instructions carefully before use to ensure patient safety and the effectiveness of the surgical procedure. Hu-Friedy's traceability and manufacturing quality ensure compliance with the expectations of clinicians specialized in implant and periodontal surgery.

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