Osteotomy Kit - Helmut Zepf (47.962.38) - Delynov
The Insert d'ostéotomie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.962.38.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 47.962.38 osteotomy insert?
The Helmut Zepf osteotomy insert, bearing reference 47.962.38, is a specialized instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed in medical stainless steel, this piezotome accessory is intended for bone surgery procedures. It presents as a robust bone surgery tip, developed to meet the requirements of oral surgery and implantology practitioners. This device is classified as a manual instrument in the manufacturer's nomenclature, ensuring standardized integration into dental care protocols.
What are the clinical indications for this dental bone surgery insert?
This dental surgery insert is primarily indicated for osteotomy procedures within the oral cavity. In clinical practice, it is used by dental surgeons and implantologists for the precise cutting of bone tissue, preparation of implant sites, or the creation of bone flaps. As an ultrasonic osteotomy insert, it allows for fine management of hard structures during alveolar remodeling phases. Its use is strictly reserved for qualified healthcare professionals mastering bone surgery techniques.
What are the technical characteristics of reference 47.962.38?
The Helmut Zepf 47.962.38 osteotomy insert is manufactured from medical grade stainless steel, selected for its mechanical strength. This device belongs to Class I of medical devices. It is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which requires a complete processing procedure before its first use. Its design is optimized to ensure compatibility with compatible bone surgery systems, although verification of this compatibility with other products must be performed beforehand by the practitioner.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer concerns known hypersensitivity or intolerance to metals. Since the instrument is composed of medical stainless steel, contact with the patient can trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the procedure, 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 use of this dental surgery insert.
What are the maintenance and reprocessing precautions?
All Helmut Zepf products must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is imperative to perform a thorough visual inspection to detect potential damage such as cracks, breaks, or defects on the cutting edges. The use of damaged or worn products is formally prohibited. Due to its design and the materials used, there is no defined maximum limit of processing cycles, but visible wear must remain the primary criterion for replacing the bone surgery tip.
Who is the manufacturer and what standards are respected?
This insert is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. The device complies with Class I medical device regulations. The manufacturer emphasizes that the instrument must be handled exclusively by healthcare professionals. Compliance with cleaning and sterilization protocols is a sine qua non condition to guarantee the safety and efficacy of the instrument during osteotomy procedures in dental offices or hospital environments.
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Specifications
| Manufacturer | Helmut Zepf |
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