Osteotomy Set - Helmut Zepf (47.962.28) - Delynov

What is the Helmut Zepf osteotomy insert (47.962.28)?

The Helmut Zepf osteotomy insert, bearing reference 47.962.28, is a specialized manual instrument for bone surgery. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is designed to meet the requirements of oral surgery. It belongs to the category of reusable consumables (CONSO) and is classified as a Class I device according to current regulations. Its rigid structure allows for efficient force transmission during bone cutting maneuvers, while ensuring the durability necessary for repeated sterilization cycles.

What are the clinical indications for this instrument?

This instrument is indicated for all dental and oral surgery procedures requiring an osteotomy. Its main use concerns the cutting, removal, or modification of bone tissue, whether in the context of pre-implant surgeries, complex extractions, or alveolar ridge regularizations. As a manual dental instrument, it offers the practitioner the tactile sensitivity essential for precision movements near sensitive anatomical structures. It is exclusively reserved for use by qualified healthcare professionals.

What are the technical characteristics of the 47.962.28 insert?

The Helmut Zepf 47.962.28 osteotomy insert is characterized by its manufacture from high-quality medical stainless steel. This material is chosen for its corrosion resistance and its ability to maintain the integrity of the cutting edges after several usage cycles. The product is delivered non-sterile and must undergo a complete cleaning, disinfection, and sterilization protocol before its first use and after each subsequent use. The design of the instrument does not define a maximum cycle limit, but requires rigorous visual inspection to detect any cracks or wear on the sharp edges.

What are the contraindications for the use of this insert?

The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or metal intolerance. Contact with this medical stainless steel instrument may trigger a reaction in allergic patients. If a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and appropriate clinical measures must be initiated. It is therefore recommended to check the patient's allergic history before any intervention using this type of metallic instrumentation.

What are the maintenance and reprocessing precautions?

The reprocessing of the Helmut Zepf osteotomy insert is based on a strict cycle: cleaning, disinfection, and sterilization. Before any use, the practitioner must check for the absence of visible damage such as cracks, breaks, or defects on the active parts. The use of a damaged or worn product is strictly prohibited to guarantee patient safety and the efficiency of the surgical gesture. Although no maximum cycle limit is set due to its robust design, compatibility with other cleaning and sterilization products must be verified beforehand by the professional user.

Who is the manufacturer and what standards are respected?

The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device complies with Class I device regulations. The manufacturer imposes strict safety instructions, including the obligation to process the product before its first use since it is delivered non-sterile. Compliance with cleaning and sterilization protocols is essential to maintain the device's conformity with public health requirements and ensure patient protection during surgical acts.

State of the art

Surgical medical consumables play a decisive role in operative safety.