Trephine. Internal Diameter 10.0 MM - Helmut Zepf (08.912.10)

What is the Helmut Zepf 10.0 MM INTERNAL DIAMETER TREPHINE?

The 10.0 MM INTERNAL DIAMETER TREPHINE, referenced under code 08.912.10 by the manufacturer Helmut Zepf, is a precision rotary instrument used in oral surgery. Designed in medical stainless steel, this device is specifically developed for drilling and harvesting bone cores. Its robust structure allows for a clean and controlled cut of the cortical and cancellous bone. This 10mm dental trephine is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, requiring a complete cleaning, disinfection, and sterilization protocol before its first use in the office or operating room. It is a manual instrument intended exclusively for healthcare professionals trained in bone surgery techniques.

What are the clinical indications for this trephine?

This implant trephine drill is indicated for various bone surgery interventions. Its internal diameter of 10.0 mm makes it particularly useful for harvesting cylindrical autologous bone grafts, often necessary during ridge augmentation or sinus lift procedures. It can also be used for the excision of calcified tissues or for creating access wells during complex surgeries. In implantology, it facilitates the removal of integrated implants or the preparation of specific sites. The use of this bone surgery trephine must be performed with adequate irrigation to avoid any overheating of the surrounding tissues, thus ensuring the viability of the bone harvest performed.

What are the technical characteristics of this instrument?

The Helmut Zepf trephine (reference 08.912.10) is defined by a precise internal diameter of 10.0 mm, adapted to the needs of dental surgeons and implantologists. Manufactured from high-quality medical stainless steel, it features cutting edges designed for long-lasting efficiency. As a Class I device, it meets the safety requirements for manual dental instruments. Before each use, the practitioner must imperatively check for the absence of visible damage such as cracks, breaks, or defects on the cutting edges. The use of a worn or damaged product is strictly prohibited to ensure patient safety and the precision of the surgical act.

What are the contraindications for the use of this device?

The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Contact with the medical stainless steel instrument can trigger an allergic reaction in certain sensitive patients. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and the necessary medical measures must be taken. It is therefore recommended to check the patient's allergic history before any use. Furthermore, the use of this instrument is reserved exclusively for qualified healthcare professionals, and its use on unsuitable anatomical structures constitutes a technical contraindication.

What are the maintenance and sterilization precautions?

As this trephine is delivered non-sterile, a complete reprocessing cycle is mandatory before the first use and after each subsequent use. The process includes thorough cleaning, disinfection, and sterilization. Due to the design of the instrument and the materials used, Helmut Zepf specifies that there is no defined maximum limit for processing cycles, as long as the instrument shows no signs of wear or degradation. The practitioner must visually inspect the 10mm trephine drill to detect any trace of corrosion or blunting of the cutting parts. Compatibility with other cleaning products and sterilization equipment must also be verified beforehand to maintain the integrity of the stainless steel.

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 trephine is classified as a Class I medical device according to current regulations. The manufacturer follows rigorous quality protocols for the production of its manual dental instruments, ensuring compliance with medical standards for the stainless steel used. Safety information, including warnings on hypersensitivity and reprocessing instructions, are provided in accordance with the Class Ir (MDC0483) guidelines. By choosing a Helmut Zepf instrument, healthcare professionals ensure they are using a tool designed by a manufacturer recognized for its technical expertise in dental surgery.

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