Osteotomy Instrument - Helmut Zepf (47.945.33)
The Ostéotome marque jaune, convexe, angulé, Ø 2.8 / 3,3 mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.945.33.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf yellow mark osteotome?
The yellow mark osteotome, referenced under code 47.945.33 by Helmut Zepf, is a high-precision manual dental instrument. Manufactured from medical stainless steel, this tool features a convex tip and an angulated structure specifically designed for oral surgery interventions. Its robust design allows direct handling by the practitioner to act on alveolar bone structures. This device belongs to the category of reusable consumables, requiring a strict cleaning and sterilization protocol before each use. It is distinguished by its yellow color marking, facilitating its identification within the osteotomy range of the manufacturer Helmut Zepf Medizintechnik GmbH.
What are the clinical indications for this dental surgery osteotome?
This instrument is primarily indicated for implant site preparation in situations where bone density is insufficient. As a manual instrument, it is used to condense cancellous bone, thereby increasing the primary stability of the implant. Its convex shape is ideal for progressively pushing back the sinus floor during crestal approach sinus lift procedures or for the expansion of narrow ridges. The use of this osteotome is reserved exclusively for health professionals qualified in oral surgery and implantology. It allows for precise tactile control during the shaping of the implant housing, minimizing the removal of bone material in favor of its peripheral densification.
What are the technical characteristics of the 47.945.33 osteotome?
The Helmut Zepf osteotome features a progressive diameter from 2.8 mm to 3.3 mm, which corresponds to preparation standards for intermediate implant diameters. Its angulated geometry is a major technical asset for reaching posterior maxillary sectors with optimal ergonomics. The tip is of the convex type, promoting axial compression rather than cutting. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is classified as Class I according to medical device regulations. It is delivered non-sterile and must imperatively undergo a complete decontamination cycle, including cleaning, disinfection, and sterilization, before its first use and after each clinical intervention.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer concerns intolerance or hypersensitivity to metals. Since the instrument is composed of medical stainless steel, contact with an allergic patient may trigger an adverse reaction. If such a hypersensitivity reaction occurs during the surgical act, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, the use of the instrument is contraindicated if it shows visible damage such as cracks, breaks, or defects on the edges. The use of worn or damaged products compromises therapeutic safety and the integrity of the patient's tissues.
What are the maintenance and reprocessing precautions?
Due to its stainless steel composition and design, there is no defined maximum limit for reprocessing cycles, as long as functional integrity is preserved. Before each use, the practitioner must check for the absence of wear or deformation. The mandatory protocol includes thorough cleaning, disinfection, and systematic sterilization. As Helmut Zepf products are delivered non-sterile, this step is critical upon receipt of the equipment. It is also recommended to check the compatibility of the osteotome with other instruments used during surgery. Any sign of corrosion or surface degradation must lead to the immediate disposal of the instrument to avoid any risk of contamination or intraoperative complications.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with Class I of the current regulations for manual dental instruments. The manufacturer imposes strict guidelines regarding safety and use, emphasizing that the instrument is exclusively reserved for healthcare professionals. Although the source text does not explicitly specify the CE marking number, the product meets the manufacturing requirements for medical devices of its class. The traceability and quality of the stainless steel used guarantee compliance with hospital standards for reusable surgical instruments.
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Specifications
| Manufacturer | Helmut Zepf |
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