Osteotome with screw - Helmut Zepf (47.937.10) - Delynov

What is the Helmut Zepf 47.937.10 screw osteotome?

The Helmut Zepf screw osteotome (reference 47.937.10) is a precision manual instrument specifically developed for bone surgery and guided bone regeneration (GBR). Manufactured from high-quality medical stainless steel, this device is designed to withstand mechanical stress during clinical interventions. It belongs to the category of Class I instruments according to medical device regulations. This tool is distinguished by its screw mechanism, offering a specific approach compared to classic impaction models, thus allowing different management of bone density during implant site preparation.

What are the clinical indications for this instrument?

This dental surgery osteotome is indicated for oral surgery procedures requiring precise manipulation of bone tissue. It is primarily used in implantology for ridge expansion or preparation of recipient sites, particularly in cases of guided bone regeneration (GBR). Using an osteotome kit including this type of screw device allows the surgeon to exert controlled pressure on the alveolar walls. It is suitable for healthcare professionals performing pre-implant surgery procedures where modification of the bone architecture is necessary to guarantee the primary stability of implants.

What are the technical characteristics of this osteotome?

The Helmut Zepf osteotome bears the technical reference 47.937.10. Its design is based on the use of medical stainless steel, guaranteeing standard biological compatibility for reusable surgical instruments. The device is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and between each patient. As a manual instrument, it does not contain electronic components. Its structure is designed to allow ergonomic handling while ensuring the efficient transmission of the force necessary for osteotomy maneuvers.

What are the contraindications for the use of this device?

The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns patients with known hypersensitivity or intolerance to metals, particularly medical stainless steel. A hypersensitivity reaction can be triggered during contact between the instrument and the tissues. If such a reaction occurs during the surgical procedure, the procedure must be immediately interrupted and appropriate medical measures must be taken. It is the responsibility of the practitioner to check the patient's allergic history before any intervention with this instrument.

What are the maintenance precautions and risks of wear?

Before each use, it is crucial to inspect the instrument for any visible damage such as cracks, breaks, or defects on the active parts. The use of a damaged or worn product is strictly prohibited. Due to its design and the materials used, there is no defined maximum limit of processing cycles, but compatibility with other cleaning and sterilization products must be verified beforehand. The reprocessing process must include complete cleaning followed by sterilization to maintain the integrity of the device and the safety of the operating field.

Who is the manufacturer and what standards are respected?

This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Germany. The product is classified as a Class I medical device (Class Ir according to certain reprocessing specifications). It meets the safety and performance requirements for manual dental instruments. In accordance with the manufacturer's guidelines, this equipment is exclusively reserved for qualified healthcare professionals. Compliance with cleaning and sterilization protocols is imperative to guarantee compliance with hospital hygiene standards and ensure the longevity of the instrument in daily practice.

State of the art

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