Screwing Device - Helmut Zepf (47.525.12) - Delynov

What is the Helmut Zepf (47.525.12) screwing device?

The Helmut Zepf screwing device, referenced under code 47.525.12, is a manual dental instrument specifically designed for surgical interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is crafted from high-quality medical stainless steel, ensuring compatibility with rigorous sterilization processes. As a Class I device, it meets the regulatory requirements for non-invasive or short-term invasive instruments used in dental practices. Its structure is optimized to allow precise screwing of components during surgical or prosthetic phases, thus ensuring stable and secure handling for the practitioner.

What are the clinical indications for this instrument?

This screwing instrument is indicated for any dental surgery procedure requiring manual handling of screwing components. Its primary use is found in implantology, where it serves as an implant screwing instrument for the placement of cover screws, healing abutments, or fixation screws. It is exclusively reserved for use by qualified healthcare professionals. The manufacturer's official indication defines this product as a manual dental instrument intended to assist the surgical gesture during the assembly or disassembly phases of compatible devices within the oral cavity.

What are the technical characteristics of device 47.525.12?

The Helmut Zepf screwing device is characterized by its manufacture in medical stainless steel, a material chosen for its corrosion resistance and durability against reprocessing cycles. Although there is no defined maximum limit for the number of use cycles, the manufacturer emphasizes the importance of checking for the absence of visible damage such as cracks, breaks, or defects on the edges before each intervention. This device is delivered non-sterile and must imperatively follow a complete protocol of cleaning, disinfection, and sterilization before its first use and between each patient.

What are the contraindications for the use of this device?

The main medical contraindication related to the use of this instrument is known hypersensitivity or intolerance to metals 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 stopped immediately and necessary clinical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible signs of wear, cracks, or deformations, as this could compromise patient safety and the effectiveness of the surgical gesture.

What are the maintenance and reprocessing precautions?

Like any reusable dental surgery instrument, this screwing device requires strict maintenance. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The manufacturer specifies that it is crucial to perform complete cleaning to remove all residue before the sterilization phase. Due to the robust design and materials used, the number of achievable treatment cycles depends on the physical condition of the tool. The user must check compatibility with other products used simultaneously and discard any instrument showing defects on the cutting edges or structure.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer produces instruments in compliance with European medical device regulations. This specific product is classified as Class I according to regulatory criteria. It is important to note that the products are delivered non-sterile, placing responsibility on the healthcare professional for the implementation of validated sterilization protocols. The traceability and quality of the medical stainless steel used guarantee a reliable tool for screwing in dental surgery, subject to compliance with the instructions for use and safety provided by Helmut Zepf.

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Surgical medical consumables play a decisive role in operative safety.