Luer Bone Rongeur 15 cm - Helmut Zepf (42.324.15) - Delynov
The Pince-Gouge Luer de 15 cm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 42.324.15.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 15 cm Luer bone rongeur by Helmut Zepf?
The 15 cm Luer bone rongeur, referenced under code 42.324.15 by Helmut Zepf, is a manual surgical instrument specifically designed for oral and maxillofacial surgery interventions. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, it features a robust structure suitable for handling hard tissues. This Class I instrument is delivered non-sterile and requires a complete reprocessing protocol before each use. Its ergonomic design and total length of 15 cm allow for a precise grip during fine bone resection procedures.
What are the clinical indications for this dental surgery bone rongeur?
The use of this dental surgery bone rongeur is indicated for all procedures requiring osteotomy or regularization of bone surfaces. In clinical practice, it is primarily used for alveoloplasty after multiple extractions, the removal of protruding bone spicules, or ridge remodeling within the framework of pre-implant surgery (GBR). It allows the surgeon to cut and remove small bone fragments in a controlled manner. Its application is strictly reserved for qualified healthcare professionals mastering oral surgery techniques.
What are the technical characteristics of this instrument?
The Luer bone rongeur (ref 42.324.15) is characterized by a length of 15 cm, offering optimal leverage for interventions in posterior or anterior zones. It is designed in medical stainless steel, a material chosen for its resistance to repeated sterilization cycles and its standard biocompatibility. As a Class I device, it meets the manufacturing requirements of Helmut Zepf Medizintechnik GmbH. The manufacturer specifies that, given the design and materials used, there is no defined maximum limit for the number of processing cycles, subject to prior visual inspection.
What are the contraindications for the use of the Luer bone rongeur?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity to metal components. A metal intolerance reaction in the patient may occur following contact with the medical stainless steel of the instrument. If such a hypersensitivity reaction manifests during the intervention, the procedure must be immediately interrupted and necessary clinical measures must be taken. It is therefore imperative to check the patient's allergic history before any surgical handling with this manual instrument.
What maintenance and safety precautions should be followed?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. The reprocessing process must be complete to guarantee aseptic safety. It is crucial to inspect the instrument before each intervention to detect any visible damage, such as cracks, breaks, or defects on the cutting edges. The use of a damaged or worn product is strictly prohibited. Furthermore, compatibility with other devices used during surgery must be verified beforehand by the practitioner.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer produces manual instruments compliant with regulatory requirements for Class I medical devices (Class Ir according to the mentioned MDC0483 marking). The product is delivered non-sterile, leaving the responsibility for the final sterilization cycle to the healthcare professional. Compliance with cleaning and sterilization protocols is essential to maintain the conformity and safety of the instrument during its use in dental offices or hospital environments.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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