Insertion Osteotome (New Osteotome) - Delynov - Helmut Zepf (47.937.13)

What is the Helmut Zepf insertion osteotome?

The insertion osteotome (reference 47.937.13) is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. Manufactured from medical stainless steel, this device is specifically developed for oral surgery procedures requiring precise bone manipulation. As implantology instrumentation, it is intended to assist the practitioner during the critical stages of recipient site preparation. This product is delivered non-sterile and belongs to Class I of medical devices, ensuring compliance with basic regulatory requirements for reusable surgical instruments.

What are the clinical indications for this instrument?

This instrument is indicated as a manual dental instrument for bone and implant surgery procedures. Its primary role is to assist the surgeon in the insertion and adjustment of components within the alveolar bone. It is used to prepare, condense, or dilate implant sites according to established clinical protocols. Its use is strictly reserved for qualified healthcare professionals, such as dental surgeons and implantologists, trained in hard tissue manipulation techniques in a sterile environment.

What are the technical characteristics of the 47.937.13 osteotome?

The Helmut Zepf insertion osteotome, bearing technical reference 47.937.13, is characterized by its manufacture from high-quality medical stainless steel. Although specific dimensions are not detailed, its design is optimized for the transmission of manual forces during insertion. As it is a Class I instrument, it meets the durability standards necessary to undergo repeated cycles of cleaning, disinfection, and sterilization. Its monobloc structure ensures the rigidity indispensable for work on cortical and cancellous bone.

What are the contraindications for the use of this osteotome?

The main contraindication identified by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals. Since the instrument is composed of medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to check the patient's allergic history before any use of this manual instrument.

What are the maintenance and sterilization precautions?

All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use and after each subsequent use. Before each intervention, the practitioner must visually inspect the instrument to detect potential damage such as cracks, breaks, or defects on the active parts. It is formally prohibited to use a damaged or worn product. Due to its design and materials, there is no defined maximum limit of processing cycles, but compatibility with other cleaning products must be verified beforehand.

Who is the manufacturer and what standards are respected?

The official manufacturer of this osteotome is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (or Class Ir for certain reprocessing procedures according to the MDR text). The manufacturer ensures that the products are delivered non-sterile and must undergo a complete reprocessing protocol before use. Compliance with German manufacturing standards guarantees that the provided implantology instrumentation meets the safety and performance requirements for professional manual dental surgery procedures.

State of the art

Surgical medical consumables play a decisive role in operative safety.