Osteotome number 6520S straight 7.5mm - Hu-Friedy - Delynov
The Ostéotome #6520S droit 7.5mm - 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 #6520S straight 7.5mm osteotome - Hu-Friedy - Delynov?
The #6520S osteotome is a manual surgical instrument developed by the manufacturer Hu-Friedy, a recognized player in dental instrumentation. This specific model features a straight configuration with a working tip calibrated at 7.5mm. It is designed to intervene on maxillary or mandibular bone structures during specific surgical protocols. As a Class I medical device, it meets regulatory requirements for use in a sterile environment after reprocessing. Its rigid structure allows for direct transmission of the force applied by the practitioner, ensuring controlled manipulation of hard tissues.
What are the clinical indications for this Hu-Friedy instrument?
The use of this osteotome is indicated in oral surgery and implantology for the atraumatic preparation of implant sites. It is particularly requested for bone condensation in low-density areas, allowing for improved primary stability of the implant. Its application also extends to crestal sinus lift techniques and alveolar ridge expansion procedures. The instrument allows for the progressive pushing back of the bone without material removal, thus preserving the patient's bone capital. It is strictly reserved for qualified healthcare professionals mastering these surgical techniques.
What are the technical characteristics of the #6520S osteotome?
The Hu-Friedy #6520S osteotome is distinguished by its straight shaft, offering direct access and optimal visibility to anterior or easily accessible operative areas. The 7.5mm dimension mentioned in its technical specifications corresponds to the diameter or specific graduation of its active part, allowing for precise calibration of the osteotomy. Manufactured by Hu-Friedy Mfg. Co., LLC, this instrument benefits from the brand's industrial expertise in metallurgy and surface finishing. It is designed to withstand repeated autoclave sterilization cycles, in accordance with the hygiene protocols in force in dental surgery practices.
What are the contraindications for the use of this device?
According to information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is exclusively reserved for duly trained healthcare professionals. Although specific contraindications are not detailed in the MDR raw text, general principles of oral surgery apply: use is prohibited in cases of uncontrolled systemic pathologies preventing surgical intervention or in the presence of an acute local infection at the operative site. The practitioner must evaluate bone density and available volume before any manipulation to avoid complications such as unwanted cortical fractures.
What are the precautions for use and maintenance for this non-resorbable instrument?
As a non-resorbable metallic instrument, the #6520S osteotome requires a rigorous maintenance protocol. Before the first use and after each intervention, the device must be cleaned, disinfected, and sterilized according to the Hu-Friedy manufacturer's instructions. It is imperative to check the integrity of the working part (absence of deformation or corrosion) before each surgical procedure. Particular attention must be paid when using surgical mallets so as not to damage the proximal end of the instrument. Compliance with the instructions for use is essential to guarantee patient safety and the longevity of the tool.
Who is the manufacturer and what standards are respected by the osteotome?
The #6520S osteotome is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I according to current regulations. The manufacturer emphasizes that the use of this instrument is strictly reserved for healthcare professionals. Although specific CE marking is not mentioned in the source data, the product is distributed by Delynov in compliance with the traceability and conformity requirements applicable to Class I devices. Users are invited to carefully read the instructions for use provided by Hu-Friedy before any clinical implementation.
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| Manufacturer | Hu-Friedy |
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