Separation Kit BONE KIT - Helmut Zepf System (47.099.50) - Delynov
The Kit de Séparation BONE KIT - Système Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.099.50.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the BONE KIT Separation Kit Helmut Zepf?
The BONE KIT Separation Kit (reference 47.099.50) is a manual instrumentation set developed by the manufacturer Helmut Zepf Medizintechnik GmbH. This system is specifically designed for oral surgery interventions requiring direct action on the tooth or dental apparatus. Manufactured from medical stainless steel, this Class I device guarantees robustness adapted to the constraints of clinical procedures. This bone separation kit allows surgeons to have dedicated tools for the critical phases of tissue and bone manipulation, ensuring a technical response to the requirements of modern implantology and surgical periodontology.
What are the clinical indications for this dental bone kit?
The Helmut Zepf surgery bone kit is indicated as a manual dental instrument during surgical treatments involving work on the tooth or dental apparatus. In clinical practice, it is used to facilitate the separation and preparation steps during a ridge expansion kit protocol or the use of a dental bone expander. Its intended purpose is to assist the practitioner in the controlled modification of hard structures. The use of this device is strictly reserved for qualified healthcare professionals, ensuring application in accordance with current surgical protocols for bone and implant surgery.
What are the technical characteristics of the Helmut Zepf system (47.099.50)?
The Helmut Zepf system is characterized by a medical stainless steel design, a material chosen for its compatibility with the requirements of dental surgery. As a Class I device, it meets safety standards for non-invasive or short-term invasive manual instruments. The kit includes specific elements identified under technical reference 47.099.50. It is imperative to check for the absence of visible damage, such as cracks, breaks, or defects on the cutting edges, before each use. The product design and materials used do not allow for the definition of a maximum limit of processing cycles, as this depends on the wear observed by the practitioner.
What are the contraindications for the use of this ridge expansion kit?
The main contraindication related to the use of the BONE KIT Separation Kit Helmut Zepf is known hypersensitivity or intolerance of the patient to metals. Since the instrument is composed of medical stainless steel, contact can trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the manufacturer specifies that the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any manipulation with these surgical instruments.
What are the maintenance and sterilization precautions?
Helmut Zepf Medizintechnik GmbH products are delivered non-sterile and require a strict protocol before any use. All instruments must be cleaned, disinfected, and sterilized before the first use, as well as before each subsequent use. It is essential to perform a complete cleaning to remove all residues. Before the surgical act, the practitioner must meticulously inspect each component to detect any signs of wear or structural damage. The use of damaged or worn products is formally prohibited to guarantee patient safety and the effectiveness of the surgical gesture. Compatibility with other products used simultaneously must also be verified beforehand.
Who is the manufacturer and what standards are respected?
The BONE KIT Separation Kit is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the traceability and compliance of its instruments intended for professional use in dental surgery. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to maintain the performance of the device. As a manual stainless steel instrument, it benefits from the expertise of a recognized manufacturer in the field of precision instrumentation, meeting the specific needs of dental surgeons and implantologists.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Helmut Zepf |
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