Periodontal Ligament Knife Number 1 Posterior Series Black [PT1X] - Hu-Friedy - Delynov

What is the Hu-Friedy #4, posterior, Black Line, left periotome?

The Hu-Friedy #4 Black Line periotome is a high-precision surgical instrument intended for oral surgery. This specific model is designed for the left posterior sectors. It is distinguished by its Black Line finish, a characteristic unique to high-end instruments from the manufacturer Hu-Friedy. This instrument is structured to be inserted into the narrow ligament space between the root of the tooth and the alveolar bone. As a Class I device, it meets the regulatory requirements for reusable non-invasive or transiently invasive surgical instruments. Its design aims to offer optimal cutting efficiency during the initial stages of dental avulsion, while maintaining increased visibility for the practitioner thanks to its dark coating which reduces reflections under operating light.

What are the clinical indications?

The clinical indications for this Hu-Friedy periotome primarily concern atraumatic dental extractions in the left posterior areas. It is used to section the fibers of the periodontal ligament before the use of elevators or forceps. This step is crucial in implant surgery to maximize the preservation of the alveolar bone plates, thus facilitating immediate or delayed implant placement under optimal conditions. The instrument is particularly indicated when access to the left molars and premolars requires a specific angulation that only a left posterior model can offer. Its use is strictly reserved for qualified healthcare professionals, in accordance with the directives of the manufacturer Hu-Friedy Mfg. Co., LLC, thus ensuring an application compliant with current oral and periodontal surgery protocols.

What are the technical characteristics?

The #4 periotome is characterized by a thin and sharp blade, specifically oriented for the left posterior quadrant. The Black Line technology applied by Hu-Friedy to this instrument improves the contrast between the instrument, the bone, and the soft tissues, while offering a harder and smoother surface. This technical finish reduces friction during insertion into the desmodontal space. The ergonomics of the instrument are designed to transmit controlled force without compromising the tactile sensitivity required during luxation. As a Class I product, it is designed to withstand repeated cleaning and sterilization cycles in dental offices or hospital environments. The dimensions and curvature of the working part are calibrated to reach difficult-to-access areas without damaging adjacent anatomical structures.

What are the contraindications for use?

According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is exclusively reserved for duly trained healthcare professionals. Although the raw MDR text does not list specific medical contraindications related to the material, general contraindications to oral surgery apply. It must not be used for elevation movements with excessive force that could lead to the fracture of the active tip, as the periotome is a ligament cutting instrument and not a force lever. The practitioner must carefully read the instructions before use to ensure the clinical status of the patient matches the use of the instrument. Any uncontrolled systemic pathology that may interfere with oral surgery constitutes an indirect contraindication to the surgical act involving this device.

What are the maintenance and handling precautions?

As the #4 Black Line periotome is a Class I reusable instrument, it requires a rigorous decontamination and sterilization protocol after each use. Practitioners must follow Hu-Friedy's instructions regarding enzymatic cleaning and autoclave sterilization to preserve the integrity of the Black Line coating. It is recommended to visually inspect the instrument before each intervention to detect any signs of wear or deformation of the blade. Careful handling is required to avoid dulling the cutting part. Compliance with sterilization parameters guarantees not only asepsis but also the longevity of the steel and the special coating. As indicated by the manufacturer located in Chicago, this instrument must be handled with care to maintain its cutting properties essential for alveolar preservation.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is Hu-Friedy Mfg. Co., LLC, with its headquarters located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This periotome is classified as a Class I medical device. Hu-Friedy is a globally recognized manufacturer for the quality of its dental and periodontal surgery instruments. The product complies with the regulatory requirements in force for medical devices in this category. The labeling and instructions for use emphasize that the instrument is reserved for healthcare professionals. Compliance with Hu-Friedy manufacturing standards ensures that each periotome meets strict precision criteria, necessary for delicate surgical interventions. The practitioner is invited to consult the attached instructions for any additional information regarding safety and usage standards.

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