Straight Osteotome Set - Helmut Zepf (47.940.00) - Delynov
The Jeu d'ostéotomes droits - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.940.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf straight osteotome set?
The Helmut Zepf straight osteotome set (reference 47.940.00) is a collection of manual instruments specifically developed for oral and implant surgery. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, these instruments are designed for precise manipulation of bone structures. This implantology osteotome kit consists of straight shafts allowing for direct force transmission during bone condensation or expansion procedures. As Class I devices, they meet the safety requirements for invasive instruments for temporary use, ensuring optimal reliability during critical phases of implant site preparation.
What are the clinical indications for this osteotome set?
The osteotome set is indicated for any surgical intervention requiring work on the tooth or dental apparatus. In clinical practice, the straight dental osteotome is mainly used by dental surgeons and implantologists for implant bed preparation, particularly in cases of low-density bone. It allows for lateral and apical bone compaction, thereby increasing the primary stability of the implant. These instruments are also utilized during crestal sinus lift procedures or for the expansion of narrow ridges, offering rigorous manual control over the modification of alveolar bone structures.
What are the technical characteristics of these instruments?
This dental osteotome kit is characterized by its medical stainless steel construction, a material chosen for its strength and compatibility with repeated sterilization cycles. Technical reference 47.940.00 designates a straight configuration, ideal for anterior sectors or direct access areas. Helmut Zepf Medizintechnik GmbH delivers these products non-sterile, requiring a complete protocol of cleaning, disinfection, and sterilization before the first use and after each procedure. The instrument design does not define a maximum limit of processing cycles; the lifespan depends on the absence of visible damage such as cracks, breakages, or defects on the cutting edges.
What are the contraindications for the use of these osteotomes?
The main medical contraindication related to the use of these medical stainless steel instruments is hypersensitivity or metal intolerance in the patient. Contact with the instrument can trigger an allergic reaction in sensitive subjects. The manufacturer Helmut Zepf specifies that if such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. It is therefore crucial to evaluate the patient's allergic history before any use of this surgical equipment in the mouth.
What are the maintenance and safety precautions?
Patient safety and instrument longevity rely on strict maintenance. All instruments in the osteotome set must be cleaned, disinfected, and sterilized before the first use and between each patient. Before each procedure, the practitioner must imperatively inspect the device to detect any visible damage or wear, such as cracks or blunt cutting edges. The use of damaged or worn products is strictly prohibited. Furthermore, compatibility with other products used during surgery must be verified beforehand. This equipment is exclusively reserved for use by qualified healthcare professionals.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This osteotome set is classified as a Class I medical device, in accordance with current regulations on manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used. Although specific CE marking is not detailed in the source data, compliance with German and European manufacturing standards for Class I surgical instruments is inherent to Helmut Zepf production, guaranteeing a reliable tool for the requirements of modern implant surgery.
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Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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