Osteotomy instrument - Helmut Zepf (47.942.20) - Delynov

What is the Helmut Zepf osteotomy instrument (47.942.20)?

The osteotomy instrument with the reference 47.942.20 is a manual dental device designed by the manufacturer Helmut Zepf Medizintechnik GmbH. It belongs to the category of surgical instruments (INSTRU) and is manufactured from high-quality medical stainless steel. This device is specifically structured to meet the requirements of surgical interventions on hard tissues in the oral environment. As a Class I device, it is intended exclusively for professional use by qualified healthcare practitioners. Its robust design ensures direct handling during critical phases of bone modification, while respecting the rigorous manufacturing standards of the German brand.

What are the clinical indications for this instrument?

This instrument is indicated for any oral surgery procedure requiring a manual osteotomy. Its primary use involves the controlled cutting, remodeling, or removal of bone segments. It is particularly relevant during pre-implant or periodontal surgeries where precise intervention on the alveolar bone is required. According to the Helmut Zepf manufacturer specifications, it is a versatile manual dental instrument. It serves as a support tool for the practitioner during the preparation of recipient sites or to correct specific bone defects, thus ensuring optimal preparation before the placement of implants or other reconstruction devices.

What are the technical characteristics of this instrument?

The Helmut Zepf osteotomy instrument (47.942.20) is characterized by its integral composition in medical stainless steel, a material chosen for its resistance and its ability to withstand sterilization cycles. This device is delivered non-sterile and must imperatively undergo a complete protocol of cleaning, disinfection, and sterilization before its first use, as well as between each patient. The manufacturer emphasizes that, given the design and materials used, there is no defined maximum limit for the number of processing cycles, as long as the instrument does not show visible damage. A rigorous inspection is necessary before each use to detect any cracks or wear of the cutting edges.

What are the contraindications for the use of this device?

The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns the patient's known hypersensitivity to metallic components. Since the instrument is manufactured from medical stainless steel, contact may trigger an allergic reaction or metal intolerance in certain sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary clinical measures must be taken. It is therefore recommended to check the patient's allergic history before any use. Furthermore, the use of the instrument is strictly prohibited if it shows signs of visible wear, breakage, or defects on the sharp parts.

What are the maintenance and reprocessing precautions?

As this device is non-resorbable and intended for repeated use, it requires strict maintenance. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to check for the absence of visible damage such as cracks or ruptures before each intervention. Never use damaged or worn products, as this could compromise patient safety and the effectiveness of the surgical act. The manufacturer specifies that compatibility with other products used simultaneously must be verified beforehand. Reprocessing depends on the physical state of the instrument, with achievable cycles being determined by rigorous maintenance and the absence of functional wear.

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 complies with European regulatory requirements for medical devices, classifying this instrument as Class I. Although specific CE marking is not detailed in the provided sources, the product meets the safety and performance standards defined for manual dental instruments. Traceability is ensured by the reference code 47.942.20. The manufacturer insists that this equipment is exclusively reserved for healthcare professionals, guaranteeing use in accordance with modern dental and oral surgery standards.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.