Osteotomy Kit II - Helmut Zepf (47.949.95) - Delynov
The Kit d'ostéotomie II - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.949.95.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Osteotomy Kit II Helmut Zepf (47.949.95)?
The Osteotomy Kit II, referenced under code 47.949.95 by Helmut Zepf, is a set of manual instruments specifically dedicated to bone surgery. This dental osteotomy set is manufactured from medical-grade stainless steel, ensuring compatibility with rigorous sterilization protocols in the practice. As a Class I device, it meets the regulatory requirements for non-invasive or invasive instruments for temporary use. The design of this bone surgery kit is based on the expertise of Helmut Zepf Medizintechnik GmbH, offering practitioners reliable equipment for cutting and manipulating hard tissues.
What are the clinical indications for this instrument set?
This kit is indicated for any intervention requiring a manual dental instrument during oral surgery procedures. It is primarily used to perform osteotomies, bone segmentations, or implant site preparations. This bone surgery set allows for a direct manual approach, offering the surgeon increased tactile sensitivity during the cutting or remodeling of the alveolar bone. It is particularly suitable for ridge expansion protocols or bone graft harvesting, where the precision of Helmut Zepf instrumentation ensures optimal management of hard tissues.
What are the technical characteristics of this osteotomy kit?
The Osteotomy Kit II is characterized by its full construction in medical stainless steel, a material chosen for its corrosion resistance and durability. The instruments included in this dental osteotomy kit are designed to be reprocessed without a defined maximum number of cycles, provided the physical integrity of the tool is preserved. The manufacturer Helmut Zepf specifies that each component must undergo complete cleaning, disinfection, and sterilization before the first use and after each subsequent use. Maintenance includes a rigorous visual inspection to detect any cracks, breaks, or defects on the cutting edges.
What are the contraindications for the use of these instruments?
The main medical contraindication lies in the patient's known hypersensitivity or intolerance to metals, particularly the medical stainless steel used by Helmut Zepf Medizintechnik GmbH. If a hypersensitivity reaction is triggered upon contact with the instrument, the procedure must be immediately interrupted and necessary clinical measures must be taken. Furthermore, the use of instruments showing visible damage such as cracks, breaks, or blunt cutting edges is strictly prohibited, as this could compromise patient safety and the effectiveness of the surgical procedure.
What are the maintenance and reprocessing precautions?
Helmut Zepf products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before any use. It is crucial to check compatibility with other products used simultaneously. Due to the robust design and materials used, there is no defined maximum limit for processing cycles, but the service life depends on the state of wear. The practitioner must systematically discard any damaged instrument. This surgical osteotome set is strictly reserved for trained healthcare professionals, ensuring handling in accordance with the state of the art in dental and implant surgery.
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 respects quality standards for the production of dental instruments. The kit is classified as a Class I medical device according to current regulations. The manufacturer's instructions emphasize the importance of compliance with cleaning and sterilization protocols to maintain the conformity and safety of the device. Each instrument in the Osteotomy Kit II is the result of precise industrial expertise, aiming to provide dental surgeons with high-performance tools for their daily interventions.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Helmut Zepf |
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