Osteotomy Set - Helmut Zepf (47.962.33) - Delynov

What is the Helmut Zepf osteotomy insert (47.962.33)?

The Helmut Zepf osteotomy insert, referenced under code 47.962.33, is a specialized instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed for bone surgery, this tool is crafted from high-quality medical stainless steel, ensuring compatibility with the requirements of daily clinical practice. This device falls into the category of consumables for oral surgery and implantology interventions. As a manual instrument, it is intended for the precise manipulation of hard tissues. Its design meets the needs of practitioners seeking a reliable osteotomy insert for their operative protocols.

What are the clinical indications for this insert?

The intended use for this instrument, according to data from the manufacturer Helmut Zepf Medizintechnik GmbH, is that of a manual dental instrument. In clinical practice, the osteotomy insert is indicated for cutting and remodeling procedures of bone structures. It is particularly requested during dental osteotomy phases, whether for implant site preparation, ridge expansion, or the creation of bone flaps. Its use is reserved exclusively for qualified healthcare professionals, thus ensuring an application compliant with care standards in oral and maxillofacial surgery.

What are the technical characteristics of the 47.962.33 insert?

The Helmut Zepf osteotomy insert is defined by its technical reference 47.962.33. Manufactured from medical stainless steel, it presents resistance adapted to the mechanical constraints of osteotomy. This device belongs to Class I according to medical device regulations. It is delivered non-sterile by the manufacturer, which requires a rigorous processing protocol before any use. The characteristics of the steel used allow for efficient energy transmission during cutting gestures, while maintaining structural integrity through repeated cleaning and sterilization cycles, although no maximum cycle limit is defined by the manufacturer.

What are the contraindications for the use of this instrument?

The main contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns metal intolerance. A hypersensitivity reaction in the patient can be triggered upon contact with the medical stainless steel instrument. If such a reaction occurs during the intervention, the procedure must be stopped immediately and the necessary clinical measures must be taken. Furthermore, it is strictly forbidden to use a product showing visible damage or wear, such as cracks, breaks, or defects on the cutting edges, in order to guarantee the safety of both the patient and the practitioner.

What are the maintenance and sterilization precautions?

As Helmut Zepf products are delivered non-sterile, a full reprocessing cycle is mandatory before the first use and after each subsequent use. This process includes cleaning, disinfection, and sterilization. It is crucial to inspect the insert before each intervention to detect any trace of wear or damage. Compatibility with other devices used during surgery must also be verified beforehand. Due to its design and the materials used, the manufacturer does not establish a maximum limit for processing cycles, leaving the healthcare professional with the responsibility of evaluating the functional state of the instrument.

Who is the manufacturer and what standards are respected?

This insert is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The device is classified as Class I (or Class Ir according to certain reprocessing specifications), which attests to its compliance with regulatory requirements for manual surgical instruments. The manufacturer ensures the traceability and quality of the materials, particularly the medical stainless steel used. As a Class I device, it meets the safety and performance standards applicable to dental instruments, thus guaranteeing a reliable tool for piezo surgery insert or manual osteotomy interventions.

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