Zepf-Line Raspatory - Helmut Zepf (41.864.13) - Delynov

What is the Zepf-Line Helmut Zepf periosteal elevator?

The Zepf-Line periosteal elevator, referenced under code 41.864.13, is a high-quality manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed for oral surgery, this instrument is made of medical stainless steel, ensuring compatibility with rigorous sterilization protocols in dental practices. As a device in the Zepf-Line range, it is a robust tool intended for the manipulation of soft tissues and the exposure of bone surfaces. This device belongs to Class I of medical devices, meeting the regulatory requirements for non-invasive or invasive instruments for temporary use.

What are the clinical indications for the 41.864.13 periosteal elevator?

This periosteal elevator is primarily indicated for oral surgery, implantology, and periodontology procedures. Its clinical role consists of detaching the periosteum from the alveolar bone to create a full-thickness flap. It is used during the extraction of impacted teeth, the placement of implants, or during guided bone regeneration surgeries. The use of this Helmut Zepf instrument allows the practitioner visual and physical access to the surgical field while maintaining soft tissues at a distance in a stable manner. Its application is strictly reserved for qualified healthcare professionals mastering dental surgical techniques.

What are the technical characteristics of this instrument?

The Helmut Zepf 41.864.13 periosteal elevator is characterized by its manufacture in high-performance medical stainless steel. It is delivered non-sterile, which requires a complete processing protocol before the first use as well as between each patient. Characteristics include structural resistance allowing it to withstand the leverage forces necessary for tissue detachment. The manufacturer specifies that due to its design and the materials used, there is no defined maximum limit for processing cycles (cleaning, disinfection, sterilization), subject to a prior visual inspection to detect any cracks, breaks, or defects on the active parts.

What are the contraindications to the use of this device?

The main contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity or intolerance to metals. As the instrument is composed of medical stainless steel, contact with the patient can trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use an instrument showing visible damage, such as cracks or excessive wear of the edges, to ensure patient safety and the effectiveness of the surgical gesture.

What are the maintenance and sterilization precautions?

Like any reusable Class I instrument, the periosteal elevator must follow a strict reprocessing cycle. Before the first use and after each subsequent use, it must be cleaned, disinfected, and sterilized. Helmut Zepf Medizintechnik GmbH emphasizes the importance of checking for the absence of residues or damage before sterilization. The use of damaged or worn products is prohibited. Compatibility with other cleaning and disinfection products must also be verified beforehand by the professional. Compliance with these safety instructions ensures the longevity of the instrument and prevents risks of cross-contamination in a surgical environment.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This periosteal elevator is a Class I medical device (Class Ir according to certain reprocessing specifications). It complies with the current safety and performance requirements for manual dental instruments. The manufacturer ensures the traceability and quality of the stainless steel used, meeting international medical standards. As a Helmut Zepf product, it benefits from the expertise of a recognized manufacturer in the field of dental instrumentation, guaranteeing that each instrument is suitable for the intended professional use in oral surgery.

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