Bone-Spreader Osteotome #4.50 Convex Bayonet 5.0mm - Hu-Friedy - Delynov

What is the convex Bone-Spreader #4.50 Osteotome?

The Bone-Spreader #4.50 Osteotome is a manual surgical instrument developed by Hu-Friedy, a recognized manufacturer in the field of dental instrumentation. This device is characterized by a 5.0mm convex active tip and a bayonet-configured handle. Its structure is specifically designed for interventions requiring precise manipulation of bone tissue. As a convex osteotome, it is used to prepare the implant recipient site by modifying the density or volume of the bone through compaction or expansion. This product belongs to the category of consumables and reusable instruments distributed by Delynov, ensuring a response to the requirements of operating theaters specialized in oral surgery.

What are the clinical indications for this instrument?

The use of this instrument is indicated during implant surgeries requiring ridge expansion or crestal sinus lift. The bone spreader surgery allows for the condensation of cancellous bone and the progressive widening of the implant socket without removal of bone material. Its 5.0mm convex tip is particularly suitable for wide sites or the final stages of site preparation. The bayonet design is a major technical indication for the posterior areas of the jaw, where straight access is limited by the mouth opening or adjacent anatomical structures. This device is exclusively reserved for healthcare professionals trained in osteotomy and implant placement techniques.

What are the technical characteristics of this osteotome?

The technical characteristics of the Bone-Spreader #4.50 Osteotome include a working diameter of 5.0mm, ideal for bone expansion protocols of intermediate to large diameter. The active part features a convex geometry, designed to push bone walls laterally or vertically during tapping or manual pressure. The bayonet handle offers an ergonomic offset that improves direct visibility of the surgical site. Manufactured by Hu-Friedy Mfg. Co., LLC, this instrument meets the brand's quality standards. It is classified as a Class I medical device, which corresponds to non-invasive or transiently invasive surgical instruments, reusable after cleaning and sterilization according to the manufacturer's protocols.

What are the contraindications for the use of this device?

According to information provided by the manufacturer Hu-Friedy, the use of this osteotome is strictly reserved for qualified healthcare professionals. General contraindications include any clinical situation where mechanical bone expansion could compromise the integrity of the ridge, such as insufficient residual bone thickness or excessive fragility of the cortical walls. Although the raw MDR text does not list specific contraindications related to materials, it is the practitioner's responsibility to assess the risks of allergies or sensitivities to the usual metal components of surgical instruments. Use is prohibited for any application not intended by the manufacturer or by persons not authorized to practice oral surgery.

What are the maintenance precautions for this non-resorbable instrument?

As a metal surgical instrument and not a resorbable device, the Bone-Spreader #4.50 Osteotome requires a rigorous decontamination and sterilization protocol between each patient. Before the first use and after each intervention, the practitioner must refer to the instructions for use for the recommended autoclave cycles. It is crucial to inspect the 5.0mm convex tip for any signs of wear or corrosion that could alter its performance during bone expansion. Compliance with the cleaning instructions provided by Hu-Friedy ensures the longevity of the instrument and patient safety. Careful handling is required to preserve the precise geometry of the bayonet handle.

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 medical device is classified as Class I according to current regulations. Hu-Friedy is a globally recognized manufacturer for the quality of its dental surgery instruments. The product is distributed by Delynov to meet the needs of implantology experts. In accordance with regulatory requirements, users must read the instructions carefully before any use. Although specific CE marking is not detailed in the source data, compliance with Class I indicates conformity with safety and performance requirements for reusable surgical instruments intended for healthcare professionals.

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