Sharp 8mm Wide Pointed Burin - Helmut Zepf (47.949.13) - Delynov

What is the Helmut Zepf 8mm pointed chisel?

The 8mm pointed chisel, referenced under code 47.949.13 by Helmut Zepf, is a manual instrument specifically designed for bone surgery. Manufactured from high-quality medical stainless steel, this surgical chisel features a pointed tip and a working width of 8mm. It belongs to the Class I device category, ensuring compliance with regulatory standards for non-invasive or short-term invasive instruments. Its robust structure allows for efficient force transmission during bone cutting or separation stages in a clinical setting.

What are the clinical indications?

This bone chisel is primarily indicated for oral surgery procedures requiring precise manipulation of bone structures. As a pointed osteotome, it is used by dental surgeons and implantologists to divide alveolar ridges, remove exostoses, or prepare the implant site. Its use is strictly reserved for qualified healthcare professionals. It is used in reconstructive surgery protocols where manual mechanical action is required to selectively sculpt or fragment bone tissue.

What are the technical characteristics of this instrument?

The Helmut Zepf dental surgical chisel is distinguished by its 8mm width and pointed profile, optimizing penetration into hard tissues. Designed by Helmut Zepf Medizintechnik GmbH, it is manufactured from medical stainless steel, a material chosen for its mechanical resistance and ability to withstand reprocessing cycles. The instrument is delivered non-sterile, which requires a strict cleaning and sterilization protocol before the first use and between each patient. Its technical reference 47.949.13 allows for precise identification within the Helmut Zepf range.

What are the contraindications for use?

The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns metal intolerance or hypersensitivity. Contact of medical stainless steel with an allergic patient can trigger a hypersensitivity reaction. If such a reaction occurs during the procedure, the procedure must be stopped immediately and necessary medical measures must be taken. Additionally, the use of the instrument is prohibited if visible damage, such as cracks, breaks, or defects on the cutting edges, is found during pre-operative inspection.

What are the maintenance and reprocessing precautions?

All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use and after each subsequent use. It is crucial to inspect the product for any signs of wear or corrosion before the procedure; never use damaged products. Due to the design of the instrument and the materials used, there is no defined maximum limit for the number of achievable processing cycles. Durability depends on compliance with the manufacturer's safety and cleaning instructions, as well as prior verification of compatibility with other products.

Who is the manufacturer and what standards are met?

The official manufacturer of this chisel is Helmut Zepf Medizintechnik GmbH, headquartered in Seitingen-Oberflacht, Germany. This device is classified as Class I according to the current medical device regulations. The manufacturer ensures the traceability and quality of the stainless steel used to meet the requirements of healthcare professionals. Although the specific CE marking is not detailed in the provided sources, compliance with manufacturing standards for manual dental instruments is guaranteed by Helmut Zepf's expertise in the surgical instrumentation sector.

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Surgical medical consumables play a decisive role in operative safety.