Root Elevator 3 mm - Helmut Zepf (17.001.11) - Delynov
The Élévateur à racines 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: 17.001.11.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Helmut Zepf 3 mm root elevator?
The 3 mm root elevator, referenced under code 17.001.11, is a precision manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed for oral surgery, this instrument is crafted from medical stainless steel, a standard material for surgical instrumentation guaranteeing resistance adapted to mechanical stresses during extractions. This device belongs to Class I according to current regulations. It consists of a working part 3 mm wide, optimized for insertion into the periodontal space to mobilize the tooth root before its final removal.
What are the clinical indications for this 3mm dental elevator?
This 3mm dental elevator is indicated for tooth extraction procedures, specifically for root luxation. Its primary clinical role is to separate the tooth from its alveolar attachment by applying controlled pressure. It is used by dental surgeons and implantologists to facilitate the avulsion of fractured roots or teeth with decayed crowns. The instrument allows for the widening of the socket and the breaking of the periodontal ligament, making the extraction less invasive for the surrounding tissues. It is particularly useful in the preparatory phases for implant placement where preserving the integrity of the bone plate is paramount.
What are the technical characteristics of this instrument?
The Helmut Zepf elevator (reference 17.001.11) features a 3 mm active part. It is manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH in Germany. As a Class I device, it meets the safety requirements for non-invasive or short-term invasive manual instruments. The product is delivered non-sterile, which necessitates a strict processing protocol before the first use. Its design is engineered to provide a stable grip, allowing the practitioner to exert the necessary leverage forces during root luxation maneuvers in a clinical setting.
What are the contraindications for the use of this instrument?
The main medical contraindication documented by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. As the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and the necessary medical measures must be taken. Apart from this specific sensitivity to metallic components, the use of the instrument must be limited to qualified healthcare professionals mastering surgical extraction techniques.
What are the maintenance and sterilization precautions?
Helmut Zepf products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use, as well as between each patient. The reprocessing process must be complete. Before each use, the practitioner must visually inspect the instrument to detect any visible damage or wear, such as cracks, breaks, or defects on the cutting edges. It is formally discouraged to use a damaged or worn instrument. Due to the design and materials used, there is no defined maximum limit of processing cycles, but verifying the functional state remains the responsibility of the professional.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with manufacturing standards for Class I medical devices. The regulatory text mentions the Class Ir (MDC0483) classification for reprocessing. The instrument must be used exclusively by trained healthcare professionals. Compliance with cleaning and sterilization protocols is essential to guarantee patient safety and the longevity of the medical stainless steel used. Helmut Zepf ensures the traceability of its devices via precise technical references such as code 17.001.11.
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