Fissure former diameter 1.9 mm (M4X0.5) - Delynov - Helmut Zepf (26.120.321TI) - Delynov

What is the Helmut Zepf 1.9 mm fissure former?

The Helmut Zepf 1.9 mm fissure former is a specialized manual dental instrument designed for oral and implant surgery interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is made of medical stainless steel, ensuring compatibility with rigorous cleaning and sterilization protocols. It is distinguished by its precise diameter of 1.9 mm and its technical threading referenced M4X0.5. As a Class I device, it meets the quality requirements for non-invasive or short-term invasive instruments. Its structure is optimized to offer direct and efficient handling during the preparation of surgical sites, while respecting the manufacturing standards of the German medical industry.

What are the clinical indications for this instrument?

The intended use of this instrument, as defined by the manufacturer Helmut Zepf, is that of a manual dental instrument. In clinical practice, the fissure former is used by dental surgeons and implantologists for the preparation, shaping, or rectification of bone sites and fissures. Its 1.9 mm diameter allows for targeted intervention during the drilling or preparation phases of the implant site. It is particularly suitable for procedures requiring manual instrumentation to refine the geometry of the operative site before the placement of devices or to facilitate access during complex periodontal or maxillofacial surgeries. Its use is strictly reserved for qualified healthcare professionals.

What are the technical characteristics of the fissure former (M4X0.5)?

The Helmut Zepf fissure former features precise technical specifications to meet the needs of modern implantology. It has a working diameter of 1.9 mm, allowing for high precision during surgical movements. The M4X0.5 technical reference indicates a specific threading that defines its compatibility with other systems or instrument handles. Manufactured in medical stainless steel, this device is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. It must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use, as well as between each patient. Its robust design maintains the integrity of the cutting edges and threads over several processing cycles, although no maximum limit of cycles is defined.

What are the contraindications for the use of this device?

The main documented medical contraindication for the use of this instrument is known hypersensitivity or intolerance to metals. Since the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. The manufacturer specifies that in the event of a hypersensitivity reaction during the intervention, the procedure must be immediately stopped and the necessary medical measures must be taken. Additionally, it is formally contraindicated to use the product if it shows visible damage or wear, such as cracks, breaks, or defects on the cutting edges, as this could compromise patient safety and the effectiveness of the surgical act.

What are the maintenance and reprocessing precautions?

As the fissure former is a non-sterile instrument upon delivery, a strict reprocessing protocol is mandatory. Before the first use and after each subsequent use, the instrument must be cleaned, disinfected, and sterilized. The practitioner must carefully inspect the instrument to detect any sign of wear or corrosion. Due to its design and the materials used, there is no defined maximum limit for processing cycles, but compatibility with other cleaning products must be verified beforehand. It is crucial never to use a damaged instrument. Compliance with these decontamination steps is essential to prevent cross-infections and guarantee the longevity of the medical stainless steel used by Helmut Zepf.

Who is the manufacturer and what standards are respected?

This fissure former is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The device is classified as Class I according to the current regulations on medical devices. Manufacturing follows the rigorous standards imposed for manual surgical instruments, using high-quality materials such as medical stainless steel. Compliance with the cleaning and sterilization procedures recommended by Helmut Zepf ensures the instrument's conformity with health safety requirements. As a Class I device, it is designed to offer constant reliability to dental surgery professionals, subject to use and maintenance in accordance with the manufacturer's technical instructions.

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