Insertion Osteotome (New Osteotome) - Delynov - Helmut Zepf (47.937.12) - Delynov
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: 47.937.12.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf insertion osteotome?
The insertion osteotome (reference 47.937.12) is a precision manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed for bone and implant surgery, this tool is made of high-quality medical stainless steel. It belongs to the category of consumables reusable after sterilization. Its structure is optimized to allow rigorous handling during the critical phases of implant preparation. As a Class I medical device, it meets the safety requirements for short-term invasive interventions in the oral cavity, offering practitioners a reliable tool for localized bone expansion or condensation.
What are the clinical indications for this instrument?
This osteotome is mainly indicated for oral and implant surgery procedures requiring manual preparation of the bone site. It is used by dental surgeons for the precise insertion and compaction of cancellous bone to improve bone density around the future implant. Its use is common in crestal sinus lift techniques or for thin ridge expansion. Purchasing this type of osteotome allows for the preparation of the implant housing while preserving the patient's bone capital through a less invasive approach than conventional rotary drilling in certain specific clinical configurations.
What are the technical characteristics of the 47.937.12 osteotome?
The Helmut Zepf insertion osteotome, bearing technical reference 47.937.12, is characterized by its medical stainless steel construction, guaranteeing corrosion resistance and durability during reprocessing cycles. It is a non-sterile instrument upon delivery, requiring a full cleaning, disinfection, and sterilization protocol before each use. Its ergonomic design is studied to transmit the practitioner's manual force axially and precisely. Compatibility with other instruments in the Helmut Zepf range must be verified before the intervention to ensure optimal operative fluidity during the recipient site preparation sequences.
What are the contraindications for the use of this osteotome?
The main medical contraindication documented by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance of the patient to metals, particularly the medical stainless steel used in the instrument's composition. In the event of a hypersensitivity reaction during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, the use of the instrument is strictly prohibited if visible damage is detected, such as cracks, breaks, or defects on the active parts, as this could compromise patient safety and the effectiveness of the surgical procedure.
What are the maintenance and sterilization precautions?
As this instrument is non-resorbable and intended for repeated use, it must undergo rigorous reprocessing. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to inspect the instrument for any signs of wear or corrosion before the surgical act. The manufacturer specifies that due to the design and materials, there is no defined maximum limit of treatment cycles, as long as the physical integrity of the tool is preserved. Use is strictly reserved for qualified healthcare professionals mastering aseptic protocols.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Germany. This product is classified as a Class I medical device according to current regulations. The manufacturer ensures the compliance of its production processes to meet the quality standards required in dental surgery. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the performance of the instrument. Each unit is identified by a precise reference (47.937.12) allowing traceability within the dental practice, in accordance with professional medical device management requirements.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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