Round 4.5 mm Elevator by Helmut Zepf (17.020.01)

What is the Helmut Zepf 4.5 mm round elevator?

The Helmut Zepf 4.5 mm round elevator is a specialized manual instrument for oral surgery. Designed by Helmut Zepf Medizintechnik GmbH, this device is manufactured from high-quality medical stainless steel. Its structure consists of an ergonomic handle and a rounded working part with a diameter of 4.5 mm. This instrument, identified under reference 17.020.01, is specifically developed for luxation and elevation maneuvers during avulsions. It belongs to the Class I instrument category, ensuring compliance with basic regulatory requirements for non-invasive or temporary-use invasive medical devices.

What are the clinical indications for this instrument?

This dental extraction elevator is indicated for the mobilization of teeth and roots before the use of forceps. In clinical practice, it is used to break the ligament fibers surrounding the tooth. The tip of the round dental elevator is inserted into the socket to exert controlled pressure, thereby allowing the tooth to be luxated. It is particularly useful in cases of simple or complex extractions, as well as during alveolar site preparation in pre-implant surgery. Its use is strictly reserved for qualified healthcare professionals, such as dentists and stomatologists, trained in exodontia techniques.

What are the technical characteristics of the 17.020.01 elevator?

The 4.5 mm round elevator is distinguished by its circular working tip with a precise diameter of 4.5 mm. This dimension is adapted to standard interdental and alveolar spaces. Manufactured by Helmut Zepf, the instrument is designed in medical stainless steel, a material chosen for its corrosion resistance and its ability to undergo repeated sterilization cycles. The reference code 17.020.01 allows for precise identification within the Helmut Zepf range. The product is delivered non-sterile and must imperatively undergo a complete cleaning, disinfection, and sterilization protocol before its first use in the office or operating room.

What are the contraindications for the use of this elevator?

The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals, specifically to medical stainless steel, in the patient. A hypersensitivity reaction may be triggered upon contact between the instrument and the tissues. If such a reaction occurs during the surgical procedure, the use of the instrument must be immediately discontinued and appropriate clinical measures must be taken. Furthermore, the use of an instrument showing visible damage, such as cracks, breaks, or defects on the cutting edges, is formally prohibited to guarantee the safety of the patient and the practitioner.

What are the maintenance and reprocessing precautions?

Like any reusable Class I instrument, this syndesmotome elevator requires rigorous maintenance. Before each use, the instrument must be cleaned, disinfected, and sterilized according to current hospital or office protocols. Helmut Zepf specifies that due to the design and materials used, there is no defined maximum limit of processing cycles, provided that the instrument shows no wear or damage. The practitioner must systematically check the condition of the elevator before use. Any damaged or worn product must never be used. Compatibility with other products used during the intervention must also be verified beforehand.

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 its expertise in the design of manual dental instruments. The product is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). In accordance with MDR regulations, the instrument meets the safety and performance requirements for reusable surgical instruments. Although delivered non-sterile, its medical stainless steel design allows for complete sterilization. Each device is identified by a unique technical reference, ensuring traceability within the Delynov supply chain.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.