Screw osteotome - Helmut Zepf (47.937.11) - Delynov

What is the Helmut Zepf screw osteotome?

The Helmut Zepf screw osteotome, reference 47.937.11, is a manual dental instrument specifically designed for bone surgery procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is crafted from high-quality medical stainless steel, ensuring compatibility with the rigorous requirements of the surgical environment. As an instrument in the GBR (Guided Bone Regeneration) category, it is intended for use by qualified healthcare professionals for implant site preparation or modification of alveolar structures. This product is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient.

What are the clinical indications for this instrument?

This screw osteotome is indicated for oral surgery procedures requiring manual action on bone tissue. Its primary use is within the framework of guided bone regeneration and implantology. It allows the practitioner to exert controlled pressure for bone expansion or condensation, thereby facilitating implant insertion in specific anatomical conditions. The instrument is exclusively reserved for healthcare professionals trained in oral surgery techniques. Its role is decisive in the mechanical preparation of the surgical site, where precision of manual movement is required to preserve the integrity of surrounding structures while optimizing the available bone volume.

What are the technical characteristics of reference 47.937.11?

The Helmut Zepf screw osteotome (47.937.11) is characterized by its medical stainless steel design, a material chosen for its resistance to repeated sterilization cycles. This device belongs to Class I of medical devices according to current regulations. Its structure is adapted for ergonomic handling, allowing efficient transmission of manual force during critical stages of bone surgery. Due to its design and the materials used, the manufacturer Helmut Zepf does not define a maximum limit for processing cycles, although the instrument must be visually inspected before each use to detect any cracks, breaks, or defects on the active parts.

What are the contraindications for the use of this osteotome?

The main contraindication related to the use of this Helmut Zepf screw osteotome is known hypersensitivity or intolerance to metals, and specifically to the medical stainless steel composing the instrument. If a hypersensitivity reaction occurs in the patient upon contact with the tool, the procedure must be immediately interrupted and necessary medical measures must be taken. Additionally, the use of the instrument is prohibited if visible damage is identified, such as cracks or excessive wear of the cutting edges, as this could compromise patient safety and the effectiveness of the surgical act. It is imperative to check the integrity of the product before any intervention.

What are the maintenance and sterilization precautions?

Helmut Zepf Medizintechnik GmbH products are delivered non-sterile. Before the first use, and after each subsequent use, the osteotome must undergo a complete cleaning, disinfection, and sterilization cycle. It is crucial to thoroughly clean the instrument to remove all organic residue before autoclaving. The practitioner must also verify the compatibility of this instrument with other devices used simultaneously during the intervention. A careful visual examination is required to discard any instrument showing signs of wear or structural degradation. Strict compliance with these reprocessing protocols guarantees microbiological safety and the longevity of the instrumentation in the dental practice.

Who is the manufacturer and what standards are met?

The screw osteotome is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I, in accordance with the regulatory requirements applicable to manual dental instruments. The manufacturer ensures the traceability and quality of its products through rigorous manufacturing processes in medical stainless steel. Although specific CE marking is not detailed in the source data, the product meets the safety and performance standards expected for a professional oral surgery instrument. The use of this equipment is strictly reserved for dental practitioners and oral surgeons within the scope of their clinical activity.

State of the art

Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.