Left Bernard Syndesmotome - Hu-Friedy - Delynov
The Syndesmotome Bernard gauche - 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 left Bernard syndesmotome?
The left Bernard syndesmotome is a manual surgical instrument developed by the manufacturer Hu-Friedy Mfg. Co., LLC. This device in the CONSO category is specifically designed for oral surgery procedures requiring precise separation of the periodontal ligament. Its structure is adapted for a left lateral approach, allowing the practitioner to access interproximal and periodontal spaces with great efficiency. As a Class I medical device, it meets the quality requirements of a globally recognized manufacturer in the dental instrumentation sector. This tool is a constituent element of the instrumentation necessary to prepare an extraction rigorously.
What are the clinical indications?
The left Bernard syndesmotome finds its primary indication in dental extraction syndesmotomy protocols. It is used by dental surgeons and implantologists to section the ligament fibers that hold the tooth in its socket. Its use is particularly recommended during simple or complex extractions, as well as in the preliminary phases of implant placement where preserving the integrity of the alveolar bone plate is crucial. By facilitating the initial luxation of the tooth, this Hu-Friedy instrument reduces the mechanical stress applied to the surrounding bone walls during the operative act.
What are the technical characteristics?
This medical device manufactured by Hu-Friedy Mfg. Co., LLC is characterized by a left-oriented working part, optimized for the ergonomics of the surgical gesture according to the treated quadrant. Although specific material details are not detailed in the MDR technical sheet, Hu-Friedy manufacturing standards ensure resistance adapted to the stresses of syndesmotomy. The instrument is classified as a Class I medical device, which implies rigorous monitoring of manufacturing processes. Its design allows fine insertion into the periodontium, ensuring clean separation of soft tissues from the root structure without unnecessarily damaging adjacent tissues.
What are the contraindications for use?
According to the information provided by the manufacturer Hu-Friedy, the use of this instrument is strictly reserved for qualified healthcare professionals. There are no specific medical contraindications listed in the provided technical documentation, beyond standard protocols related to oral surgery. However, the practitioner must evaluate the relevance of using the left Bernard syndesmotome based on the patient's anatomy and the condition of the periodontal tissues. As with any surgical instrument, a complete anamnesis is necessary to rule out risks related to systemic pathologies that could impact healing or increase the risk of hemorrhage during extraction.
What are the precautions for use and maintenance?
The use of this syndesmotome requires in-depth knowledge of dental extraction techniques. The manufacturer Hu-Friedy Mfg. Co., LLC specifies that it is imperative to read the instructions carefully before any use. As a Class I instrument, it must be cleaned, disinfected, and sterilized in accordance with the protocols in force in the dental office to guarantee patient safety and tool longevity. The practitioner must be careful not to exert excessive leverage forces that could compromise the integrity of the instrument's fine tip or cause damage to the bone tissue. A visual check of the instrument's condition before each procedure is recommended.
Who is the manufacturer and what standards are respected?
The left Bernard syndesmotome is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, IL 60618 USA. This medical device belongs to Class I according to current regulations. Hu-Friedy is a manufacturer recognized for its expertise in the production of high-precision surgical instruments. Compliance with Class I standards ensures that the product meets the safety and performance requirements defined for non-invasive or invasive medical devices for temporary use. Healthcare professionals can refer to the instructions provided by Delynov to ensure use in accordance with the American manufacturer's guidelines.
State of the art
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Specifications
| Manufacturer | Hu-Friedy |
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