Insertion Osteotome (New Osteotome) - Delynov - Helmut Zepf (47.937.14)
The Ostéotome d'insertion (Nouvel Ostéotome) is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.937.14.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf insertion osteotome?
The insertion osteotome, bearing reference 47.937.14, is a specialized manual instrument designed by Helmut Zepf Medizintechnik GmbH. Manufactured from high-quality medical stainless steel, this instrument is specifically developed to assist the practitioner during the critical phases of implantation. Its rigid structure and ergonomic design allow for precise manipulation within the oral cavity. As an implant insertion instrument, it meets the requirements of modern oral surgery by providing a reliable interface between the surgeon's hand and the implant device. It is delivered non-sterile and requires a complete cleaning and sterilization protocol before any clinical use.
What are the clinical indications for this instrument?
This dental osteotome is indicated for implant surgery procedures requiring manual control during implant placement. Its primary use lies in the insertion and adjustment of the implant position within the previously prepared alveolar bone. As an insertion osteotome, it is used by dental surgeons and implantologists to ensure a correct trajectory and controlled insertion. The instrument is particularly useful in clinical situations where tactile sensitivity is paramount for assessing primary stability or for orienting the implant according to the defined prosthetic treatment plan. It is integrated into the standard implant placement protocol after drilling.
What are the technical characteristics of the 47.937.14 osteotome?
The Helmut Zepf insertion osteotome (reference 47.937.14) is distinguished by its medical stainless steel construction, ensuring corrosion resistance and the durability necessary for repeated reprocessing cycles. This manual instrument is classified as a Class I device according to current regulations. Its monoblock or assembled design according to Helmut Zepf standards ensures direct transmission of the applied force. Although specific dimensions are not detailed, its geometry is optimized for access to posterior and anterior areas. It is imperative to check for any visible damage, such as cracks or defects on the functional surfaces, before each intervention to ensure operative safety.
What are the contraindications for the use of this osteotome?
The main medical contraindication documented by the manufacturer Helmut Zepf concerns known intolerance or hypersensitivity to metals, specifically to the medical stainless steel composing the instrument. If a hypersensitivity reaction occurs in the patient upon contact with the instrument, the surgical procedure must be immediately interrupted and necessary clinical measures must be taken. There are no other specific contraindications listed; however, use is strictly reserved for qualified healthcare professionals. The use of a damaged or worn instrument, or one showing cracks, is also prohibited to avoid any risk of intraoperative breakage or cross-contamination.
What are the maintenance and sterilization precautions?
Helmut Zepf products are delivered non-sterile and must imperatively follow a complete cleaning, disinfection, and sterilization cycle before the first use and after each subsequent use. Reprocessing must be carried out according to current hospital or practice protocols for Class I devices. Due to its design and the materials used, there is no defined maximum limit of treatment cycles, but functional wear must be visually monitored. It is crucial to thoroughly clean the instrument to remove any organic residue before autoclaving. Compatibility with other cleaning and disinfection products must be verified beforehand by healthcare personnel.
Who is the manufacturer and what standards are respected?
The insertion osteotome is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I, in accordance with regulatory requirements for manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used. As a Class I device, it meets the safety and performance standards applicable to reusable surgical instruments. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the longevity of the instrument and the safety of patients during implantology interventions.
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Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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