Osteotomy Instrument - Helmut Zepf (47.945.43) - Delynov

What is the convex and angled Helmut Zepf osteotome?

The Helmut Zepf osteotome (reference 47.945.43) is a high-precision manual dental instrument manufactured from medical stainless steel. This model is distinguished by its convex-shaped working part and its angled shaft, facilitating manipulation in the posterior sectors of the oral cavity. It features diameters of 3.9 mm and 4.3 mm, identifiable by a specific blue marking. As a Class I instrument, it is designed to meet the requirements of oral surgery while guaranteeing standard biocompatibility for patients without metal hypersensitivity.

What are the clinical indications for this bone surgery instrument?

This instrument is primarily indicated as an implantology osteotome for the preparation of recipient sites. Its convex shape is ideal for performing a crestal approach osteotome sinus lift, as it allows for the condensation of cancellous bone and the controlled elevation of the sinus membrane. It is also used for narrow alveolar ridge expansion, allowing for an increase in local bone density through compaction rather than subtraction, thus optimizing the primary stability of implants in low-density bone.

What are the technical characteristics of the 47.945.43 osteotome?

The Helmut Zepf osteotome features an ergonomic design with a specific angulation to improve clinical access. The working diameters are calibrated at 3.9 mm and 4.3 mm, allowing for sequential progression during the osteotomy. Manufactured by Helmut Zepf Medizintechnik GmbH, this instrument is delivered non-sterile. Its medical stainless steel composition ensures the necessary resistance to compaction forces. It belongs to the category of reusable devices, requiring a strict reprocessing protocol after each intervention to maintain its functional properties and safety of use.

What are the contraindications for the use of this instrument?

The main medical contraindication documented by the manufacturer is metal intolerance or allergy in the patient. Contact with medical stainless steel can trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary clinical measures must be taken. Furthermore, the use of the instrument is strictly reserved for qualified healthcare professionals. The use of an instrument showing visible damage, such as cracks, breaks, or defects on the edges, is formally prohibited.

What are the maintenance and sterilization precautions?

Like any reusable dental bone surgery instrument, this osteotome must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The manufacturer Helmut Zepf specifies that it is crucial to check for the absence of visible damage and wear before each use. Due to the robust design and materials used, there is no defined maximum limit for processing cycles, but the integrity of the instrument must be validated by the practitioner. Products must be cleaned and sterilized in accordance with standard hospital protocols for Class I devices.

Who is the manufacturer and what standards are respected?

This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The manufacturer is recognized for its expertise in high-quality surgical instrumentation. This product is classified as a Class I medical device according to current regulations. It complies with safety and performance requirements for manual dental instruments. Traceability is ensured by the reference 47.945.43. As a device that is non-sterile upon delivery, its final compliance depends on the user healthcare professional's adherence to cleaning and sterilization protocols.

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