Osteotomy Instrument - Helmut Zepf (47.943.28) - Delynov

What is the Helmut Zepf 47.943.28 osteotomy instrument?

The Helmut Zepf osteotomy instrument, referenced under code 47.943.28, is a manual dental instrument designed for bone surgery interventions. Manufactured from high-quality medical stainless steel, this tool is specifically structured to meet the requirements of practitioners during bone cutting or bone density modification phases. As an instrument in the INSTRU category, it benefits from the expertise of Helmut Zepf Medizintechnik GmbH, a manufacturer recognized for its mastery of stainless steel devices. This product is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use in the office or operating room.

What are the clinical indications for this osteotome?

This osteotome is primarily indicated for implant surgery and oral surgery interventions requiring direct action on bone tissue. It is used as a ridge expansion instrument to progressively widen the implant site without loss of bone substance, thus promoting better primary stability of the implant. Its application also extends to surgical osteotome for alveolar remodeling. As a manual dental instrument, it offers the surgeon a precise tactile response during site preparation, ensuring handling adapted to the specific bone density of each patient, while respecting clinical protocols for dental osteotomy.

What are the technical characteristics of this instrument?

The Helmut Zepf 47.943.28 instrument is characterized by its medical stainless steel composition, a material chosen for its resistance and compatibility with reprocessing cycles. It is a Class I device according to medical device regulations. The design of the instrument does not allow for a maximum limit of treatment cycles to be defined, as this depends on the actual wear observed by the professional. Before each use, it is imperative to inspect the instrument for any visible damage such as cracks, breaks, or defects on the cutting edges. The use of damaged or worn products is strictly prohibited to guarantee the safety of care.

What are the contraindications for the use of this instrument?

The main medical contraindication documented by the manufacturer Helmut Zepf Medizintechnik GmbH concerns metal intolerance. Contact with the medical stainless steel instrument may cause a hypersensitivity reaction in certain sensitive patients. If such an intolerance reaction manifests during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken accordingly. Apart from this specific sensitivity to metals, the instrument is reserved exclusively for use by qualified healthcare professionals trained in osteotomy and implant surgery techniques.

What are the maintenance and sterilization precautions?

Like any reusable manual dental instrument, this osteotome must strictly follow a rigorous reprocessing cycle. All instruments must be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. The manufacturer emphasizes the crucial importance of cleaning each product before proceeding with sterilization. Due to the robust design and materials used, there is no predefined limit on the number of sterilization cycles, but the lifespan of the instrument is directly linked to its physical condition. The practitioner must verify compatibility with other products used simultaneously during the surgical procedure.

Who is the manufacturer and what standards are respected?

The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This manufacturer is recognized for the production of high-precision medical devices. This product is classified as a Class I device, respecting the regulatory requirements applicable to manual dental instruments. Following the safety and use instructions provided by Helmut Zepf is essential to ensure the compliance of the device during its integration into the clinical workflow. Professionals can refer to technical reference 47.943.28 for the precise identification of the model within the Helmut Zepf osteotome range.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.