Osteotomy Tip - Helmut Zepf (47.961.33) - Delynov

What is the Helmut Zepf 47.961.33 osteotomy insert?

The Helmut Zepf osteotomy insert, bearing reference 47.961.33, is a manual dental instrument specifically developed for bone surgery procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is designed in medical grade stainless steel, ensuring compatibility with the rigorous sterilization protocols of dental practices. As a Class I device, it meets the basic requirements for non-invasive or invasive instruments for temporary use. Its structure is designed to offer direct handling by the practitioner during bone cutting or remodeling phases, integrating perfectly into the manual instrumentation arsenal for oral and implant surgery.

What are the clinical indications for this insert?

This manual instrument is indicated for osteotomy interventions within the oral cavity. Its primary use concerns bone surgery, where it allows the dental surgeon or oral surgeon to perform incisions or structural modifications of the alveolar bone. It is particularly used in the contexts of implant site preparation, bone ridge regularization, or autogenous harvesting. According to data from the manufacturer Helmut Zepf, its intended purpose is that of a manual dental instrument, which implies controlled use by a qualified healthcare professional during invasive surgical procedures requiring fine and robust instrumentation.

What are the technical characteristics of the 47.961.33 insert?

The Helmut Zepf osteotomy insert reference 47.961.33 is characterized by its medical stainless steel composition, a material chosen for its mechanical resistance and its ability to undergo repeated reprocessing cycles. It is a non-sterile instrument upon delivery, requiring complete preparation before each use. Its manual design allows for direct tactile feedback during osteotomy. The manufacturer specifies that due to the product design and the materials used, it is not possible to define a maximum limit for treatment cycles, as long as the instrument does not show visible damage such as cracks, breaks, or defects on the cutting edges.

What are the contraindications for the use of this instrument?

The main medical contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity to metals. Contact with this medical stainless steel instrument can cause an intolerance reaction in patients allergic to certain metallic components. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and the necessary clinical measures must be taken. Furthermore, the use of the instrument is strictly contraindicated if it shows visible signs of wear, cracks, or defects in the active parts, as this could compromise patient safety and the effectiveness of the surgical procedure.

What are the maintenance and reprocessing precautions?

Like any Class I instrument intended for surgery, this Helmut Zepf insert must follow a strict reprocessing protocol. Products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to visually inspect the instrument to detect any trace of corrosion, crack, or blunting of the cutting edges before integrating it into the sterilization cycle. The manufacturer emphasizes that cleaning must be complete to ensure safety. The use of damaged or worn products is prohibited. Compliance with these safety instructions ensures the longevity of the instrument and the protection of patients during osteotomy interventions.

Who is the manufacturer and what standards are respected?

The osteotomy insert is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to certain reprocessing nomenclatures). The manufacturer certifies that the instrument complies with the regulatory requirements applicable to manual medical devices. Healthcare professionals must verify compatibility with other products used during the intervention. As a regulatory Class I device, it is designed to meet German industrial quality standards, ensuring constant reliability for dental surgeons and implantologists demanding in their daily practice.

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