Osteotomy Set - Helmut Zepf (47.961.20) - Delynov

What is the Helmut Zepf osteotomy insert (47.961.20)?

The Helmut Zepf osteotomy insert, bearing reference 47.961.20, is a manual dental instrument specifically developed for bone surgery procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is designed in medical stainless steel, a standard material for surgical instrumentation ensuring the rigidity necessary for cutting procedures. This product belongs to the consumables category (CONSO) and is classified as a Class I device according to current regulations. It is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use in the mouth, as well as between each patient, to ensure optimal health safety.

What are the clinical indications for this instrument?

This insert is indicated for oral surgery procedures requiring precise osteotomy. In clinical practice, it is used by dental surgeons and implantologists for the manipulation of hard tissues, particularly during implant site preparation or during corrective surgeries of the alveolar bone. As a manual instrument, it allows direct tactile management during bone cutting. Its use is strictly reserved for qualified healthcare professionals trained in oral surgery techniques. The manufacturer specifies that the suitability of this insert with other products used during the procedure must be verified by the practitioner before any intervention.

What are the technical characteristics of the 47.961.20 insert?

Technically, this insert is distinguished by its manufacture from high-quality medical stainless steel, selected by Helmut Zepf for its mechanical resistance. Reference 47.961.20 corresponds to a specific configuration of a manual osteotome. Before each use, the practitioner must imperatively inspect the instrument for any visible damage, such as cracks, breaks, or defects on the cutting edges. The use of damaged or worn products is prohibited to maintain the efficiency of the surgical gesture and patient safety. Due to its robust design and the materials used, there is no defined maximum limit for processing cycles, as long as the integrity of the instrument is preserved.

What are the contraindications for the use of this insert?

The main contraindication related to the use of this instrument is the patient's known hypersensitivity or intolerance to metals, and more particularly to the components of medical stainless steel. Contact of the instrument with tissues can trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. It is the responsibility of the practitioner to evaluate the patient's allergic history before using this Helmut Zepf manual insert.

What are the maintenance and reprocessing precautions?

The Helmut Zepf osteotomy insert is a reusable device that requires a rigorous reprocessing cycle. As it is delivered non-sterile, it must be cleaned, disinfected, and sterilized before the first use. This process must be fully repeated after each subsequent use. Preliminary cleaning is a critical step to eliminate organic residues before sterilization. The manufacturer Helmut Zepf Medizintechnik GmbH emphasizes the importance of checking the condition of the instrument (absence of cracks or wear on the cutting edges) after each treatment cycle. The durability of the device depends directly on compliance with these maintenance instructions and careful handling by healthcare personnel.

Who is the manufacturer and what standards are met?

This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The device complies with the regulations for Class I medical devices (Class Ir according to certain reprocessing nomenclatures). Manufacturing is based on the use of medical stainless steel, ensuring the biocompatibility necessary for a temporary use invasive instrument. As a Class I device, it meets the essential safety and performance requirements defined by the manufacturer for manual dental instruments. Compliance with sterilization and maintenance protocols is essential to ensure the continued conformity of the product during its use in a dental surgery practice.

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Surgical medical consumables play a decisive role in operative safety.